Philip Morris International announced that the U.S. Food and Drug Administration (FDA) has authorized a modified risk claim for 20 varieties of ZYN nicotine pouches, marking the first such decisions for nicotine pouch products.
The U.S. Food and Drug Administration (FDA) has decided that 20 variants of ZYN nicotine pouches can be categorized as modified risk nicotine products, making ZYN the first of its kind to receive such approval.
The Food and Drug Administration (FDA) has granted permission for Philip Morris International to market its Zyn nicotine pouches with a label indicating they are less harmful than cigarettes. This decision allows for specific health claims on the product.
The Food and Drug Administration (FDA) in Mumbai has suspended six eateries due to severe hygiene violations, including the presence of rats, cockroaches, and rotting or expired food. This crackdown highlights ongoing efforts to ensure food safety standards in the city.
Lantheus Holdings, Inc. has announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application for LNTH-2501.
Stem cell technology firm Miracell has achieved a significant milestone by securing clearance from the US Food and Drug Administration (FDA) for its integrated cell-processing system.
Alvotech shares jumped after the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for a biosimilar to Entyvio for review. This development marks a significant step for Alvotech in bringing its biosimilar to market.
The Philippine Food and Drug Administration (FDA) continues to review the application for the new generation anti-dengue vaccine, Qdenga, three years after it was submitted for registration.
A report by the Brownstone Institute alleges that the US Food and Drug Administration (FDA) has covered up child deaths linked to Covid vaccines, citing former FDA Commissioner Dr. Marty Makary.
Pharmaceutical company Bayer announced that its drug Sevabertinib has been granted Priority Review status by the U.S. Food and Drug Administration (FDA), as reported by TradingView.
Marty Makary, the head of the Food and Drug Administration (FDA), has resigned from his position under pressure, having faced criticism from both sides of the political aisle.
A man was apprehended in Cagayan de Oro City, Philippines, for allegedly selling a 'kidney cleanser' food supplement that was not registered with the Food and Drug Administration (FDA).
The Food and Drug Administration (FDA) in Maharashtra has mandated that restaurants must declare the use of analogue paneer and cheese on their menus starting May 1, in an effort to combat 'paneer…
Eli Lilly has announced that the U.S. Food and Drug Administration (FDA) has requested additional clinical data regarding its experimental obesity pill, potentially delaying its approval.
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...
In an exclusive interview, Maharashtra Food and Drug Administration (FDA) chief Tukaram Munde emphasized the critical need to strengthen the agency's manpower to ensure citizens receive safe food and medicines.
Experts are raising concerns that a series of recent baby formula recalls due to bacterial contamination may be linked to staff reductions at the Food and Drug Administration (FDA) during the Trump administration, suggesting the agency is ill-prepared for such health threats.
The US Food and Drug Administration (FDA) claims that Irish pharmaceutical company Genzyme produced 'adulterated products' after inspecting its facility near Waterford city and finding significant violations.
A Food and Drug Administration (FDA) panel discussing peptides will reportedly include experts who advocate for unproven chemicals, a topic favored by figures like RFK Jr.
Tobacco stocks saw an uptick after the U.S. Food and Drug Administration (FDA) proposed a new rule concerning foreign manufacturers, signaling potential changes in the regulatory landscape for the industry.
The Food and Drug Administration (FDA) has withdrawn its complaint against Whoop regarding its blood pressure tracking tool. This decision clears the path for the health technology company.
The U.S. Food and Drug Administration (FDA) has approved a new chemical compound for use in sunscreens, which will soon allow people to enjoy sunbathing more frequently with enhanced protection.
Icelandic pharmaceutical company Alvotech has applied to the U.S. Food and Drug Administration (FDA) for market authorization for its drug AVT16, as announced in a stock exchange filing today.
The U.S. Food and Drug Administration (FDA) has granted priority review status to Roche's breast cancer drug, giredestrant. This designation accelerates the review process for drugs that could offer significant improvements over existing treatments.
Advisers to the U.S. Food and Drug Administration (FDA) have backed the XFG strain for the 2026-2027 COVID-19 vaccine update. This decision follows a routine review of vaccine composition to combat evolving variants.
An advisory committee to the U.S. Food and Drug Administration (FDA) is set to evaluate an updated COVID-19 vaccine specifically designed to target the XFG subvariant.
AstraZeneca has announced that its hypertension drug, Baxfendy, has received approval from the U.S. Food and Drug Administration (FDA). This approval marks a significant step for the treatment of hypertension.
Kyle Diamantas, a former lawyer and deputy commissioner for food, has been appointed as the new acting commissioner of the US Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) has announced a significant policy change by authorizing the sale of fruit-flavored e-cigarettes. This decision represents a major shift in the agency's approach to vaping products.
The U.S. Food and Drug Administration (FDA) is reportedly conducting an unannounced inspection at the facilities of pharmaceutical company Alvotech in Iceland.
Pharmaceutical giant AbbVie has received a rejection from the U.S. Food and Drug Administration (FDA) regarding its new wrinkle drug, citing unresolved manufacturing issues.
The U.S. Food and Drug Administration (FDA) has renewed the authorization for Philip Morris International's IQOS as a Modified Risk Tobacco Product (MRTPA).
The U.S. Food and Drug Administration (FDA) has reauthorized the marketing of IQOS as a modified risk tobacco product, making Philip Morris International the sole company with such authorizations for heated tobacco products.
Savara Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its lead drug candidate, potentially delaying its approval decision.
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).
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.
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 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.
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.
The Maharashtra Food and Drug Administration (FDA) has intensified its efforts against milk adulteration, implementing stricter regulations for the supply chain to ensure quality and safety.
The U.S. Food and Drug Administration (FDA) has listed a recall for Insulet's Omnipod insulin management system as a Class I recall, indicating the most serious type of recall.
The US Food and Drug Administration (FDA) has upgraded a recall for an estimated 650,000 bags of popular potato chip brands to its most serious level due to a potential salmonella risk.
NeuroPace, Inc. announced that its ECoG Assistant™ has received approval from the U.S. Food and Drug Administration (FDA). This approval marks a significant milestone for the company and its product in the medical device market.
The Food and Drug Administration (FDA) will hold a committee meeting in July to discuss potentially easing restrictions on peptides, which are currently sold in a gray market despite limited evidence of safety and efficacy.
The U.S. Food and Drug Administration (FDA) has issued an urgent recall for a popular sexual enhancement chocolate product, 'Boner chocolate,' after laboratory analyses revealed it secretly contained the active ingredient of Viagra, posing a dangerous health risk to consumers.
The U.S. Food and Drug Administration (FDA) has put forward a proposal to accelerate the development of gene therapies by leveraging existing scientific knowledge. This initiative aims to streamline the process for bringing new gene therapies to patients.
Advisers to the U.S. Food and Drug Administration (FDA) have recommended that COVID-19 vaccines be updated to specifically target the currently dominant variant of the virus.
An opinion article discusses the potential for new leaders at the Food and Drug Administration (FDA) to foster innovation. It likely examines how new policies or approaches could impact the industry.
The US Food and Drug Administration (FDA) is experiencing significant leadership turmoil, with a top drug regulator departing and claiming she was fired. This departure is part of a broader shakeup within the agency's drug and biologics divisions.
The US Senate has cleared the path for lawyer and financial expert Kevin Warsh to succeed Jerome Powell as the next head of the Federal Reserve. Separately, the head of the US Food and Drug Administration (FDA) has announced his resignation.
The U.S. Food and Drug Administration (FDA) has extended its review period for Biogen's Alzheimer's injection, Leqembi, delaying a decision on its approval.
The head of the Food and Drug Administration (FDA), Dr. Makary, has defended the agency's decisions to reject certain drug applications, following recent criticism.
The U.S. Food and Drug Administration (FDA) has announced that its largest ever probe into baby formula found the U.S. supplies to be safe. This reassures consumers about the quality of domestic infant formula.
The U.S. Food and Drug Administration (FDA) has taken steps to fast-track the review process for three different psychedelic drugs. This move could potentially accelerate their approval for medical use.
The U.S. Food and Drug Administration (FDA) has renewed the authorization for Philip Morris International's IQOS heated tobacco products as modified risk tobacco products.
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.
The U.S. Food and Drug Administration (FDA) has granted approval for Denali Therapeutics' new therapy designed to treat a genetic disorder in children.
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 U.S. Food and Drug Administration (FDA) plans to offer bonus payments to its staffers who successfully complete speedy drug reviews, aiming to accelerate the approval process for new medications.
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...