Biopharmaceutical company Replimune plans layoffs after the U.S. Food and Drug Administration rejected its cancer drug, impacting the company's workforce and future plans.

Biotechnology company Replimune is experiencing renewed pressure following the Food and Drug Administration's (FDA) second rejection of its primary drug asset.

MacroGenics announced that the U.S. Food and Drug Administration (FDA) has removed a partial clinical hold on its lead development program.

Waters Corporation has announced that it received FDA approval for its new at-home cervical cancer screening kit, marking a significant advancement in accessible healthcare.

Hormone drugs are experiencing a significant $6.3 billion resurgence in the market following the FDA's decision to nix previous safety warnings.

A US judge has issued a temporary pause on Louisiana's legal challenge against the Food and Drug Administration's regulations concerning an abortion drug, indicating a procedural development in the ongoing legal battle.

The Islamabad High Court (IHC) has issued an order for lawyer Salman Safdar to meet with former Prime Minister Imran Khan at 2 PM tomorrow.

Ghana's Food and Drugs Authority (FDA) has issued a public health alert regarding the discovery of falsified HIV diagnostic kits being sold on the market, raising concerns about inaccurate results and delayed treatment.

Stereotaxis has announced that it received FDA clearance for its Synchrony system and has subsequently launched the new platform, marking a significant development for the company.

GE HealthCare (GEHC) has received FDA clearance for its Photonova Spectra CT System, marking a significant advancement in medical imaging technology.

Raw Farm, a California dairy producer, has recalled cheddar cheese products following an E. Coli outbreak that has sickened nine people in three states, though the company denies its products are the cause.

Eli Lilly (LLY) has received FDA approval for its new weight management pill, Foundayo, marking a significant development in the treatment of obesity.

Ultragenyx has announced that its gene therapy has been accepted for review by the FDA once again.

ORIC Pharmaceuticals experienced a drop in its stock value after releasing early-stage trial data for its prostate cancer therapy. The market reacted negatively to the initial results of the clinical study.

The US FDA has issued a warning regarding cases of liver injury associated with a rare disease drug manufactured by Amgen.

The U.S. Food and Drug Administration (FDA) has confirmed that Amgen's drug Tavneos is linked to cases of liver injuries and deaths, as reported by the Wall Street Journal.

ImmunityBio Inc. (IBRX) has received a warning letter from the FDA regarding claims made in an advertisement for its cancer therapy.

Caribou Biosciences has seen its stock rise following the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its CAR-T cell therapy, indicating accelerated development and review for the innovative treatment.

3i Infrastructure has provided pre-close updates, detailing a €1.1 billion exit from TCR, a €300 million deal for Lefdal, and DNS:NET equity reduced to zero.

Ultragenyx has announced that its investigational new drug (IND) application for UX016, intended for the treatment of GNE myopathy, has received clearance from the FDA.

Rocket Pharmaceuticals (RCKT) has seen a commercial boost following the FDA's approval of its drug KRESLADI.

The National Agency for Food and Drug Administration and Control (NAFDAC) announced it destroyed fake and unwholesome drugs valued at over N939 million in Nigeria's South-East region.

Rocket Pharma's shares have risen following the FDA's approval of its first therapy for a deadly childhood disorder, Reuters reports.

Maharashtra FDA Minister Narhari Zirwal is embroiled in a new controversy after a video showing him with a transgender individual went viral, sparking allegations of extortion and manipulation.

Dianthus's stock rose after the U.S. Food and Drug Administration (FDA) agreed to proposed changes for the company's lead program.

Doctors are worried about the FDA's scrutiny of RSV antibody shots, which are about 80% effective in preventing severe RSV in infants, while drugmakers maintain their safety.

The U.S. Food and Drug Administration (FDA) has granted approval for Denali Therapeutics' new therapy designed to treat a genetic disorder in children.

Corcept Therapeutics shares surged after its lead drug received approval from the FDA for the treatment of ovarian cancer, marking a significant milestone for the company.

Medtronic has announced that its OmniaSecure product has received FDA approval for an expanded indication, broadening its use in medical applications.

Rezolute's stock gained following a positive meeting with the FDA regarding its lead asset, signaling potential progress for the company's drug development.

Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) has issued a nationwide alert regarding confirmed counterfeit batches of Mabthera 500mg/50ml, a cancer drug, circulating in the country.

The U.S. FDA has approved setmelanotide (IMCIVREE) for the treatment of acquired hypothalamic obesity, a significant development in managing the condition.

Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity  Taiwan News

The National Agency for Food and Drug Administration and Control, NAFDAC, has raised the alarm over the circulation of counterfeit cancer medicines, Avastin and Tecentriq—across Nigeria, raising…

Johnson & Johnson said the U.S. Food and Drug Administration approved its once-daily psoriasis pill, the first oral option to rival best-selling shots.

The Danish Royal House's former communications chief, who served for 17 years, has been appointed as Queen Margrethe's new lady-in-waiting.

NAFDAC’s DG calls for greater investment in women and children’s well-being, highlighting it as crucial for building a sustainable future for Nigeria. Read More: https://punchng.com/nafdac-dg-urges-greater-investment-in-women-childrens-well-being/

The Food and Drugs Authority (FDA) has issued an urgent public alert following the discovery of a dangerous, unregistered substance being sold under the name ‘Sukudai’.

The Fox News AI Newsletter covers the latest artificial intelligence technology advancements, including the challenges and opportunities AI presents now and for the future.

Inovio Pharmaceuticals Inc. (NASDAQ: INO) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational DNA medicine INO-3107 for the treatment of recurrent respiratory papillomatosis (RRP).

The Food and Drug Administation is approving a generic drug for a very rare genetic disorder, but not for autism

FDA launches new AI-powered system to track drug and vaccine side effects in real time, replacing outdated databases and saving $120 million annually.

Novo Nordisk has reportedly violated reporting protocols for potential side effects, according to the US Food and Drug Administration.

Vinay Prasad Is Leaving the FDA / Anthropic Sues the Pentagon  WSJ

The American authority notes alleged gaps in procedures for adverse reactions in the use of drugs for diabetes and obesity. The Danish giant launches a plan to correct course

The move comes months after the Trump administration touted leucovorin as a potential therapy for a broader group of patients with autism symptoms.

With the removal of FDA warning labels, hormone therapy to treat symptoms of menopause has grown in popularity. Now some patients are reporting delays in filling prescriptions for estrogen patches.

U.S. FDA says it met with states interested in importing cheaper drugs from Canada  The Globe and Mail

Biotechnology company stocks have seen an increase following the departure of the head of the FDA's vaccine division.

The company is recalling the affected lot (271 and 164 cartons) due to "failed tablet/capsule specifications", it stated

Dr. Vinay Prasad drew criticism for decisions that overrode agency scientists and rejected potential drugs.

FDA vaccines chief Vinay Prasad to leave regulator in April  Reuters

A nationwide candy recall has been issued and subsequently classified by the FDA into its highest-risk category. Details regarding the specific candy and reasons for the recall were not immediately available in the snippet.

Telix Pharmaceuticals saw its stock increase after its imaging agent for brain cancer received a review designation from the U.S. Food and Drug Administration (FDA).

Indian drugmaker Granules plans to tighten its oversight processes after receiving a warning from the US FDA, according to an executive.

Barrister Salman Safdar met with PTI founder Imran Khan at Adiala jail on Thursday, a day after the Islamabad High Court directed authorities to arrange the meeting. The lawyer departed without sharing details.

A federal judge has ruled that the abortion pill mifepristone can continue to be mailed nationwide for now, but warned that its FDA guidelines could face significant changes as the agency faces a six-month review deadline.

Philip Morris International is facing challenges in overcoming the US Food and Drug Administration's (FDA) concerns regarding the use of nicotine pouches.

Eli Lilly and Company (LLY) saw its price target raised by analysts following the FDA's approval of its new drug, Fundayo.

The U.S. Food and Drug Administration has declined to issue specific guidance regarding the import of prescription drugs from overseas by health programs. This decision follows a CNBC investigation that highlighted the proliferation of such programs, which regulators consider a violation of import laws.

The article discusses the misconception that testosterone is a magic cure-all for middle age, particularly for women, noting that there are currently no FDA-approved testosterone products for women.

Immunome's Chief Scientist has reduced his stake in the company, a move that comes ahead of a planned FDA submission, suggesting potential implications for the company's future.

The FDA has granted approval for a new oral weight loss pill named Foundayo, with details released on its usage and implications.

Corporate Accountability and Public Participation Africa (CAPPA) and other stakeholders have expressed support for Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) in its efforts to implement proposed sodium reduction regulations aimed at combating hypertension.

Corcept Therapeutics Incorporated (CORT) has seen gains following FDA approval for its product, though some questions regarding the company's future prospects reportedly remain.

The U.S. Food and Drug Administration (FDA) has stated that Amgen's drug Tavneos has been linked to cases of liver injuries and deaths, as reported by the Wall Street Journal.

The FDA has issued a warning regarding Amgen's drug Tavneos following reports of serious liver injury cases associated with its use.

A new Dartmouth study indicates that Telmisartan, an FDA-approved blood pressure medication, could enhance the effectiveness of certain cancer treatments against tumors.

Biogen has secured approval from the FDA for a higher dosage of its drug designed to treat a genetic disorder.

Namibia Critical Metals has amended its Lofdal joint venture agreement with JOGMEC, securing additional funding to advance the feasibility study for the rare earth project.

An opinion piece discusses India's approach at the World Trade Organization, suggesting that a constructive path forward involves deeper engagement with the IFDA and identifying areas for necessary safeguards.

Dietary supplement manufacturers are actively lobbying the FDA to approve the inclusion of peptides and other novel ingredients in their products.

Novo Nordisk has secured US FDA approval for its once-weekly insulin Awiqli, expanding its presence in diabetes care and offering a new treatment option for type 2 diabetes.

The U.S. Food and Drug Administration has approved Novo Nordisk's insulin injection for the treatment of type 2 diabetes. This approval marks a new development in diabetes management.

Kamada's new plasma center has received approval from the FDA and is now targeting EMA approval next.

The Food and Drugs Authority (FDA) in Ghana's Ashanti Region has reiterated its caution to media outlets and manufacturers, emphasizing that no product should be advertised without prior regulatory approval to ensure compliance.

People taking ‘Wegovy HD’ lost an average of 21 percent of their body weight after 72 weeks

LivaNova (LIVN) has announced that its aura6000 System has received FDA approval for the treatment of obstructive sleep apnea.

BioCardia has detailed its upcoming CardiAMP FDA submission, aiming for regulatory catalysts as trial data continues to indicate significant clinical benefits for the treatment.

The FDA has approved Wegovy HD, a higher-dose semaglutide, for weight loss in adults with obesity, promising greater weight reduction despite expert warnings about potential side effects.

ImmunityBio's stock declined after the FDA issued a warning regarding an advertisement and podcast related to its drug Anktiva.

Donald Trump and Robert F Kennedy Jr publicly advocated for leucovorin as an autism treatment, leading to a significant increase in prescriptions. The FDA subsequently approved the drug only for folate deficiency, not autism.

US FDA approves higher dose of Novo's Wegovy under new fast-track review program  Reuters

Delhi woke up to cloudy weather and light rainfall, with the minimum temperature recorded at 17.6°C. Various stations, including Safdarjung and Lodhi Road, reported several millimeters of rain.

The FDA has released new guidance concerning the use of alternatives to animal testing in various scientific and product development processes.

Lene Balleby, the former communications chief for the Danish Royal House for 17 years, has been appointed as Queen Margrethe's new lady-in-waiting.

The company further revealed that batch number B2346B16 has been linked to at least four confirmed counterfeit cases across multiple countries, including Nigeria, Turkey and the Philippines, with identical false information. The post NAFDAC alerts Nigerians to counterfeit breast cancer drug Phesgo in Nigeria appeared first on Premium Times Nigeria.

US FDA declines to approve Aldeyra's eye disorder drug, shares slump Reuters

The National Agency for Food and Drugs Administration and Control has announced a voluntary recall of all lots of the male enhancement dietary supplement MR.7 SUPER 700000 capsules, citing serious safety concerns. In a notice via its X handle on Monday, the agency said the recall follows an analysis by the US Food and Drug Read More: https://punchng.com/nafdac-recalls-male-enhancement-supplement-warns-against-consumption/

FDA warns public against unregistered ‘Sukudai’ substance  Graphic Online

Mineralys Therapeutics (MLYS) is making progress with the FDA regarding its drug for hypertension.

Praxis stock has surged an impressive 700% over the past year, with a fund investing $266 million into its pipeline, signaling strong confidence in the company's future.

Capricor Therapeutics signals potential commercialization of its drug Deramiocel, backed by a $318 million cash balance and an ongoing FDA review milestone.

Avastin, also known as bevacizumab, is a cancer medicine used in the treatment of recurrent glioblastoma in adults. The post NAFDAC warns of counterfeit Avastin cancer drug circulating in Nigeria appeared first on Premium Times Nigeria.

MANILA, Philippines—The Food and Drug Administration (FDA) on Wednesday said the controlled destruction of infant formula products, earlier recalled by Nestlé Philippines, began this week, marking…

The Food and Drugs Authority (FDA) has launched a nationwide investigation into claims that vendors are using polyethylene (plastic) in frying plantain chips to improve crispiness and extend shelf…

Vinay Prasad Is Leaving the FDA / Anthropic Sues the Pentagon  WSJ

AP Shills For Big Pharma Antidepressants With 'Bewildering' Hit Piece Check this out... The Trump FDA's top drug regulator, Dr.

Ο Αμερικανικός Οργανισμός Τροφίμων και Φαρμάκων ανακοίνωσε ότι η λευκοβορίνη δεν εγκρίνεται για τη θεραπεία του αυτισμού, παρά τις αρχικές δηλώσεις της κυβέρνησης Τραμπ.

The CEO of Axsome Therapeutics has completed a planned sale of $6 million in company options, a move made ahead of a crucial FDA decision regarding the company's products.

Vinay Prasad, an official for the Food and Drug Administration, is reportedly stepping down, which is welcome news for biotech companies.

Review of FDA records by the Environmental Working Group reveals firms are exploiting rule to send new chemicals in food system More than 100 substances widely used in common US foods, supplements…

The FDA's controversial vaccine chief, Dr. Vinay Prasad, is leaving the agency. It's the second time he has abruptly departed following decisions involving the review of vaccinations and specialty…

Vinay Prasad, the top regulator overseeing vaccines and complex treatments for difficult diseases, had previously lost his job in July before getting it back less than two weeks later.

Lantheus Announces FDA Approval of PYLARIFY TruVu™ (piflufolastat F 18) Injection  Taiwan News

US FDA approves Johnson & Johnson's blood cancer drug after speedy review  Reuters

Replimune's drug designed to treat advanced skin cancer has once again failed to receive approval from the FDA.

Boston Scientific has announced that its Asurys Fluid Management System has received clearance from the U.S. Food and Drug Administration (FDA).

Medline has been issued a warning by the FDA regarding faulty heart syringes. The warning indicates potential issues with the medical devices.

Mesoblast shares saw gains following the FDA's clearance for a study to test its drug Ryoncil in treating Duchenne muscular dystrophy.

A federal judge has ruled that telehealth abortion will remain available for now, though the abortion pill mifepristone must undergo a safety review by the FDA. A case from Louisiana seeking to ban its use via telemedicine will proceed after the review.

Due to the impact of tariffs, deals for FDA-approved drug manufacturing are increasingly relocating to Europe, indicating a significant shift in the global pharmaceutical supply chain.

ImmunityBio (IBRX) has been issued a warning by the FDA, though investment firm BTIG has indicated it will maintain a positive stance on the company's prospects.

Immunity Bio has issued a response to the Food and Drug Administration's concerns regarding the marketing materials for its product, Anktiva.

Eli Lilly's new GLP-1 weight-loss pill, Foundayo, which is the first oral GLP-1 not requiring fasting, has been approved by the Food and Drug Administration and has shown effectiveness in clinical trials, with one user losing 25 pounds.

Takeda Pharmaceutical Company has announced that its drug Rusfertide has been granted Priority Review by the FDA for the treatment of Polycythemia Vera (PV).

Context Therapeutics saw its stock rise after its lead asset was granted fast track status by the FDA.

The U.S. Food and Drug Administration has granted market approval to Eli Lilly for its new weight-loss pill, making it available soon.

Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert regarding the sale of fake and unregistered Cerelac Mixed Fruits and Wheat products in Lagos.

The FDA has announced that Amgen's drug Tavneos has been linked to instances of liver injuries and fatalities.

Agios Pharmaceuticals announced plans to pursue accelerated approval from the FDA for the expansion of its Pyrukynd drug label, leading to gains for the company.

Wearable technology company Whoop has successfully raised $575 million, achieving a $10.1 billion valuation. This funding round comes despite an ongoing rift with the FDA.

Biogen has received approval from the U.S. Food and Drug Administration for its high-dose Spinraza regimen, a treatment for spinal muscular atrophy.

Bristol-Myers Squibb has obtained FDA approval for a new treatment targeting Hodgkin’s Lymphoma.

Students from Gammel Hellerup Gymnasium have successfully resolved the long-standing debate over whether the young Viking Halfdan, whose remains are exhibited at Kroppedal Museum, was male or female.

ARS Pharma has obtained FDA approval to eliminate the age restriction on its product, Neffy, broadening its potential use.

Rocket Pharma's stock saw a significant increase after the FDA approved its gene therapy, signaling a positive development for the company.

Health Secretary Kennedy indicated that the government is likely to loosen restrictions on certain peptide treatments, which have been popular for wellness but faced stricter FDA requirements due to safety concerns.

Corcept Therapeutics (CORT) shares climbed by 19.7% after its drug Lifyorli received approval from the FDA.

Sanofi has announced that its drug Venglustat has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA).

An upcoming FDA review meeting will determine the future of Compass Pathways' depression drug candidate COMP360, as the company awaits regulatory feedback on its potential treatment.

Corcept Therapeutics has been granted FDA approval for its new cancer therapy, marking a significant development in its oncology pipeline.

FDA scientists have issued warnings that some popular peptides are ineffective and potentially dangerous, leading to criticism of figures like RFK Jr. for promoting unproven health claims.

The FDA has approved Wegovy HD, a higher-dose semaglutide, for weight loss in adults with obesity, offering a 'major jump' in potential weight reduction, with some users losing an average of 21 percent of their body weight.

GE HealthCare has secured FDA approval for its innovative photon-counting CT technology, marking a significant advancement in medical imaging.

Pfizer and Valneva's Lyme disease vaccine trial showed strong efficacy but reportedly missed a specific mark, complicating its path to regulatory approval from the FDA, as further reports confirm.

With the maximum temperature settling at 21.7 degrees Celsius at Safdarjung, 9.6 degrees below normal, Delhi logged its coldest March day since March 8, 2020, when the mercury had dropped to 21.2…

Health officials with the Trump administration have backed away from an effort to more heavily regulate indoor tanning — despite protests from medical groups that warn of the dangers of skin cancer.

MoonLake Immunotherapeutics has been upgraded by Rothschild & Co Redburn, with analysts citing the potential for FDA approval of the company's lead drug. This upgrade reflects increased confidence in the drug's market prospects.

A unit of Aurobindo Pharma's arm in Rajasthan, India, has been classified as 'Official Action Indicated' (OAI) by the U.S. Food and Drug Administration.

Lene Balleby has been appointed as Queen Margrethe's new lady-in-waiting.

Lantheus announced that the FDA has extended the review period for its radioactive diagnostic kit.

The government’s crackdown on e-cigarettes created a more dangerous black market.

Valstybinė maisto ir veterinarijos tarnyba (VMVT) informuoja, kad JAV Ligų kontrolės ir prevencijos centras (CDC) kartu su JAV Maisto ir vaistų administracija (FDA) ir valstijų institucijomis tiria…

By Adesina Wahab  To some people, the standard of education has fallen. To some, moral decadence in schools has been elevated to a great height and probably that was why the National Agency for Food and Drugs Administration and Control, NAFDAC, recently said students in basic schools are consuming sachet alcohol. However, Mr Ayopo Somefun, the Southwest  […] The post Our children are not alcoholics, Somefun,PTA leader, tells NAFDAC  appeared first on Vanguard News.

Sen. Josh Hawley introduces legislation to revoke FDA approval of abortion drug mifepristone, sparking strong criticism from Planned Parenthood officials.

A specific fund has invested $170 million in a biotech stock that has seen a 1,040% increase in value over the past year, coinciding with an FDA review for its breast cancer drug.

FDA Unveils New Platform For Tracking Side Effects Authored by Zachary Stieber via The Epoch Times (emphasis ours), The Food and Drug Administration on March 11 made public a new, consolidated platform for tracking side effects experienced by people following receipt of vaccines and drugs. The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times Officials are folding a number of existing platforms into the Adverse Event M...

Senator Josh Hawley has introduced a bill aimed at stripping FDA approval from the abortion pill mifepristone, citing it as 'inherently dangerous' and referencing research on serious side effects.

In September, Health Secretary Robert F. Kennedy Jr. touted leucovorin as a therapy that could help autistic children. Now the FDA says there is insufficient evidence

Vinay Prasad Is Leaving the FDA / Anthropic Sues the Pentagon  WSJ

The exit of Prasad from the FDA is seen as offering relief but not a complete resolution to underlying issues, indicating ongoing challenges within the regulatory body.

A key US Senator has launched an investigation into the Food and Drug Administration (FDA) regarding its denials of drugs for rare diseases.

The U.S. Food and Drug Administration (FDA) is reportedly planning to ease testing requirements for biosimilar drugs, a move aimed at making it easier and faster to bring these less expensive alternatives to market.

A Wall Street Journal opinion piece reports on Vinay Prasad's departure from the FDA, noting it is not his first time.

Exclusive | FDA’s Controversial Vaccines Chief Will Leave the Agency  WSJ

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S. Food and Drug Administration.

UniQure needs to run another trial to prove its gene therapy "actually helps people with Huntington's disease," said a senior FDA official.