An opinion piece from the Wall Street Journal details how the FDA is increasing its approval rate for drugs designed to treat rare diseases.

Robert F KennedyJr says his new appointees will help him ‘fight autism.’ But, Eric Garcia writes, many of them also contributed to his presidential campaign

The FDA has approved AbbVie's VENCLEXTA in combination with acalabrutinib for the first-line treatment of chronic lymphocytic leukemia (CLL). This approval provides a new treatment option for patients.

Reports indicate that AI-assisted medical devices, despite over 1,300 having FDA approval, might be causing injuries to patients, raising concerns about their safety and implementation.

The National Agency for Food and Drug Administration and Control (NAFDAC) has warned healthcare providers, patients, and the public about the falsification and parallel importation of three batches of a NAFDAC-registered product: Dostinex 0.5mg Tablets. The post Beware of counterfeit Dostinex tablets, NAFDAC warns appeared first on Vanguard News.

An opinion piece from The Wall Street Journal details how the FDA is increasing its approval rate for drugs designed to treat rare diseases.

NAFDAC warns of fake baby formula (SMA Gold) in Kaduna with altered expiry dates. This tampered product poses serious health risks to vulnerable infants. Read More: https://punchng.com/nafdac-warns-of-fake-expiry-dates-on-baby-formula-in-kaduna/

The Wall Street Journal publishes an opinion piece welcoming the FDA's recent decision to walk back a previous stance on a flu vaccine.

Teva and Medincell have been granted FDA review for their long-acting antipsychotic drug, marking a step forward in its potential approval.

US FDA approves Vanda's antipsychotic pill, shares climb  Reuters

Dr. Reddy's biosimilar for Bristol's Orencia is currently undergoing FDA review, marking a significant step in the development of new treatment options.

The Trump FDA has reversed its plan to ban artificial food colors, drawing criticism from experts who fear new labeling could deceive consumers about dangerous substances.

Regeneron has been granted FDA priority review for its therapy targeting a rare bone disorder, potentially accelerating its path to market.

Opinion | A Welcome FDA Walkback on a Flu Vaccine  The Wall Street Journal

FDA Reverses Course and Will Now Review Moderna’s Flu Shot  The Wall Street Journal

Sandoz has secured FDA approval to broaden the label for its drug Enzeevu, allowing its use for multiple retinal indications.

Bristol Myers has received FDA priority review for its multiple myeloma therapy, indicating a potential acceleration in the drug's approval process.

Moderna announced that the FDA has refused its application for a new mRNA flu vaccine.

Federal policies under Robert F. Kennedy Jr. that are hostile to vaccines have “sent a chill through the entire industry,” one scientist said.

H.C. Wainwright has reiterated its 'Buy' rating on Beam Therapeutics (BEAM) following the FDA's expedited approval of BEAM-302.

The FDA has refused to review Moderna's mRNA flu vaccine, drawing widespread criticism from doctors and creating division within the agency, with Health Secretary Robert F. Kennedy Jr. broadly rejecting the technology.

The Wall Street Journal covers two distinct developments: allegations of China secretly testing a nuclear weapon and the FDA's decision regarding an mRNA flu shot.

The Food and Drug Administration is proposing a system for approving customised drugs and medical treatments for patients with rare or hard-to-treat diseases

MacroGenics' stock declined following the FDA's decision to place a partial clinical hold on the company's lead drug program.

The Philippine Food and Drug Administration (FDA) has placed major retail chains Landers Superstore and S&R Membership Shopping under scrutiny after inspections revealed unregistered and improperly labeled products.

Eli Lilly’s Zepbound Gets FDA OK for Multi-Dose Pen  The Wall Street Journal

FDA proposes new system for approving customized drugs and therapies for rare diseases  AP News

An opinion piece from The Wall Street Journal details how the FDA is increasing its approval of drugs to treat rare diseases.

Nigeria's NAFDAC has conducted a major operation in Lagos, seizing banned and fake cosmetic products valued at N3 billion, as part of efforts to combat illicit trade.

NAFDAC uncovers a warehouse with over ₦3 billion in banned and fake cosmetics in Lagos, including prohibited skin-lightening soaps. Learn about the seizure Read More: https://punchng.com/video-nafdac-seizes-banned-fake-cosmetics-worth-%e2%82%a63bn-in-lagos/

Opinion | A Welcome FDA Walkback on a Flu Vaccine  The Wall Street Journal

Robert F. Kennedy Jr. and former FDA Commissioner Dr. David Kessler are uniting to address the issue of ultra-processed foods, despite their political differences.

FDA Dropping Requirement For 2 Studies For New Drug Approvals Authored by Zachary Stieber via The Epoch Times (emphasis ours), The Food and Drug Administration (FDA) will approve many new drugs based on one trial moving forward, agency leaders have said. FDA Commissioner Dr. Marty Makary in Washington on July 29, 2025. Saul Loeb/AFP via Getty Images The FDA has typically required two studies from companies seeking approval for most new drugs, although in recent years it has ap...

Nigerian officials have sealed 18 warehouses in Niger state for storing expired non-alcoholic beverages, dairy products, candies, bottled water, and pasta, some of which had already been distributed.

AbbVie has received FDA approval for its Venclexta-acalabrutinib combination therapy as a first-line treatment for chronic lymphocytic leukemia (CLL).

Opinion | A Welcome FDA Walkback on a Flu Vaccine  The Wall Street Journal

Opinion | A Welcome FDA Walkback on a Flu Vaccine  The Wall Street Journal

Moderna's stock has risen above its 20-day moving average following the FDA's review of its flu vaccine, prompting questions about its investment potential.

FDA Reverses Course and Will Now Review Moderna’s Flu Shot  The Wall Street Journal

ISLAMABAD: A distri­­ct and sessions court on Tu­­esday directed the prosecution to ensure appearance of former prime minister Imran Khan at the next hearing either in person or through a video link, while extending his pre-arrest bail in five ca­­s­es, including the attem­p­ted murder of ex-minister Mohsin Shahnawaz Ranjha. Judge Muhammad Afzal Majoka restrained police from arresting the PTI founder in the said cases and also extended the pre-arrest bail of Bushra Bibi in one related matter. The hearing was adjourned till Feb 18. During the proceedings, the PTI founder Imran Khan and Bushra Bibi were represented by their legal team. However, despite earlier directions, the former prime minister could not be produced before the court through a video link. Owing to his absence and the unavailability of his counsel, Barrister Salman Safdar, arguments on the acquittal application could not be advanced. The court subsequently directed that the PTI fou­nder must appear at the next hearing either personally or via video link. The cases against the PTI founder stem from the May 9 incidents and incl­ude charges of attempted murder, submission of fake receipts and other offences. A separate case has also been registered against Bushra Bibi for allegedly submitting fake receipts. Also, Additional Distr­ict and Sessions Judge Amir Zia extended the interim bail of Bushra Bibi in a case related to the November 26 protest. Meanwhile, ATC Judge Tahir Abbas Sipra deferred indictment proceedings in the Sangjani Jalsa case due to the non-appearance of the accused PTI lawmakers. Published in Dawn, February 18th, 2026

A top FDA scientist explains his resignation following a promotion from RFK Jr., shedding light on the circumstances surrounding his departure.

Multiple biotech and pharmaceutical companies, including Legend Biotech, Corcept Therapeutics, and Ultragenyx, have released updates on their drug pipelines, clinical trial data, and regulatory interactions, impacting market outlook.

A top FDA scientist has resigned from his position after receiving a promotion from RFK Jr., sparking questions about the circumstances of his departure.

The Food and Drug Administration's decision to reject Moderna's new flu shot has sparked discussions about the future trajectory of vaccine innovation and approval processes.

The FDA has declined to review Moderna's mRNA flu vaccine application, citing an inadequate study design, a decision the company disputes.

Pfizer announced that its drug Braftovi has received full approval from the FDA for the treatment of colorectal cancer.

The FDA has accepted Bristol Myers Squibb's New Drug Application (NDA) for Iberdomide, granting it Priority Review status. This indicates the agency's expedited review of the drug.

The FDA has issued a recall for peanut butter containers across 40 states following a troubling discovery, emphasizing consumer protection as a top priority.

The FDA has released new guidance aimed at speeding up the development process for pharmaceutical companies working on treatments for rare diseases, potentially benefiting the sector.

Opinion | FDA: How We’re Approving More Drugs to Treat Rare Diseases  WSJ

An opinion piece from the Wall Street Journal explains how the FDA is increasing its approval of drugs to treat rare diseases.

NAFDAC said the affected product carries batch number 22939510A1206 07:35, with a stated manufacturing date of 20 January 2025 and expiry date of 20 January 2027. The product also bears NAFDAC Registration Number B1-2783. The post Revalidated SMA Gold infant formula discovered in Kaduna — NAFDAC appeared first on Premium Times Nigeria.

Opinion | A Welcome FDA Walkback on a Flu Vaccine  The Wall Street Journal

The FDA has granted Breakthrough Therapy Designation to Johnson & Johnson's cancer drug, JNJ-73841937, for the treatment of advanced head and neck cancer.

FDA to reassess the safety of BHA, a preservative used in popular snack foods  Associated Press News

The FDA is set to review Savara's resubmitted Biologics License Application (BLA) for Molbreevi, indicating a new phase in the drug's regulatory process.

Roche has received FDA review for a new breast cancer therapy, marking a significant step in developing advanced treatments for the disease.

FDA chief Marty Makary addresses the contentious period for the agency, marked by significant staff and budget cuts, and discusses changes to vaccine policy and the use of compounded GLP-1s.

The FDA has issued an urgent recall for a popular supplement after three individuals in the US reported falling ill.

The FDA chief warns that the U.S. is falling behind China in early drug development and calls for faster trial approvals to address bottlenecks in hospital contracting, ethical reviews, and Investigational New Drug applications.

FDA Reverses Course and Will Now Review Moderna’s Flu Shot  The Wall Street Journal

Moderna's stock surged after the FDA reversed its stance and agreed to review the company's new flu shot.

Harmony Biosciences has been granted FDA label expansion for its drug Wakix, allowing its use in children with narcolepsy.

Top FDA Scientist Explains Why He Quit After Getting a Promotion From RFK Jr.  The Wall Street Journal

IT has been a worrying week for the PTI as the news about Imran Khan’s health became public and dominated news headlines and private conversations. From the sketchy information that came out initially, it appeared that he had some problem with his eye and has lost up to 85 per cent of his vision in that eye. This was reported by lawyer Salman Safdar, after his court-appointed visit to Khan at Adiala jail, though there had been news reports about the matter earlier. According to Safdar, the percentage was communicated to Khan by the doctors who examined him. The government’s earlier reaction appeared a bit inexplicable. It took the government days to confirm the problem, after it had been reported in the media. And then it did nothing while the Supreme Court woke up to take notice, sending Safdar to the jail. Over the weekend, there were reports that a team of doctors had been sent to the jail to examine him, while his family and personal doctors continued to wait for access. As the family and party refused to accept the government’s decision of giving access to only certain individuals (rather than the family being allowed to choose the person) the examination was carried out at the jail by doctors without any relative present. The party is trying to build up pressure through protests and sit-ins, which seems to cause no sleepless nights to the government. This is so despite reports that KP is cut off from the rest of the country. The PTI is getting criticised for this though it is hard to understand why the federal government is ignoring it. To return to Adiala, this is a good time for a reminder that health issues, especially of imprisoned political prisoners, should not be downplayed or treated lightly. For this reason, the government should provide all help possible to Khan; this includes allowing his family and personal doctors access to him, so they can take decisions on his health, instead of the government making the call on which experts should conduct the examination and which family members can be present. This reeks of callousness. The reports of Khan’s ill health have added fuel to the talk of a probable deal. However, there is a political angle to this entire crisis. The reports of Khan’s ill health have added fuel to the talk of a probable deal or ‘dheel’, as it seems to share some parallels with the platelets issue which allowed Nawaz Sharif to be freed and flown to London. In fact, the question being asked again and again in Islamabad is if this is Platelets 2, implying that some backroom deal is being worked out. It is important to point out that the rumours did not just emerge as a result of health worries but also because of the events of the past couple of weeks where the cooperation between the federal and provincial governments improved. Once this happened, the allegations of drugs and other criminal activities directed at Chief Minister Sohail Afridi gave way to praise for his cooperation with Islamabad. So once the reports of the illness emerged, it simply lent credence to rumours that something was cooking. At the moment, it is hard for those of us who live away from Constitution Avenue to comment on these rumours with any authority. And beca­u­­se I would like to feel better about my ignorance, perhaps some of those living on Constitution Avenue may also be as ill-informed as the rest of us mortals. Despite this, there is much support for the idea of a deal. For many within the PTI think it would provide respite to Khan and others and allow them to bide their time for a return to power (as in the case of other politicians in the past). On the government side, it is seen as a way to bring some stability to the situation, allowing the focus to remain on the economy. But all of this ignores a larger issue, beyond the comfort of those in power and in the opposition. In other words, beyond the level of high politics, where the players tend to be the establishment, the parties and individuals, what will this deal bring to dissatisfied people who have been feeding into the popularity and stature of Khan? Indeed, it is this anger which has resurrected Khan and the PTI each time a fatal blow has been struck in the direction of the party in what is ‘high politics’. Be it the forcible exits from the PTI of the more well-known faces or the decision to deprive the party of its symbol — popular support for it has ensured that none of these steps proved sufficient. So it is perhaps worth asking what the impact of such a ‘deal’ would be. Suppose the deal does disillusion the supporters of Khan and undermines his popularity in a way similar to Nawaz Sharif and the PML-N. (The economy and its poor performance landed the second blow on N’s popularity.) And then what options will be left for the people to still stay engaged in electoral politics. Will they opt for other, smaller political parties? Or will they look around for more radical options? The point here is that the establishment needs to realise that it not going to be enough to win over politicians to its side; this is not what will make the system more stable. For the system to be more stable, it is not enough to quieten politicians such as Sharif or Khan and then revel in the decline of their popularity. For real stability, the anger of the people will have to be understood and then addressed through a more equitable economic system and by giving them a voice. Instead of focusing on high politics, it might help if for once attention were paid to the level at which people operate and exist. After all, electoral politics in Balochistan was tamed some time ago, but stability continues to be elusive. The writer is a journalist. Published in Dawn, February 17th, 2026

Pharmaceutical company Nuvalent has provided updates on the FDA timelines for its ROS1 and ALK drugs, with $1.4 billion in cash reserves fueling its global launch strategies.