Regeneron has secured approval from the U.S. Food and Drug Administration (FDA) for its new therapy designed to treat a rare bone disorder.

The U.S. Food and Drug Administration (FDA) has proposed new regulations that would require food manufacturers to notify the agency before introducing new ingredients and additives into their products.

Biopharmaceutical company Oculis has announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding its plans to develop Privosegtor, a drug substance intended for the treatment of acute multiple sclerosis exacerbations.

Merck's new cholesterol pill has received approval from the U.S. Food and Drug Administration (FDA). This powerful new medication is expected to offer a significant treatment option for patients.

Philip Morris International has announced that the U.S. Food and Drug Administration (FDA) has approved a modified risk claim for 20 of its ZYN products. This approval signifies a significant regulatory milestone for the company.

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 U.S. Food and Drug Administration (FDA) has accepted Gilead's supplemental New Drug Application (sNDA) for its weekly Yeztugo HIV pill.

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 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 recommended that COVID-19 vaccines be updated to specifically target the currently dominant variant of the virus.

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.

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 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 heated tobacco products as modified risk 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 confirmed that Amgen's drug Tavneos is linked to cases of liver injuries and deaths, as reported by the Wall Street Journal.

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

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) has approved an mRNA flu vaccine, a development considered a major breakthrough in vaccine technology and public health. The new jab is expected to offer improved protection against influenza.

The U.S. Food and Drug Administration (FDA) has granted approval for Replimune's melanoma drug, marking a successful outcome after the company's third attempt to secure approval.

The U.S. Food and Drug Administration (FDA) has issued a nationwide recall for the thyroid medication levothyroxine.

The U.S. Food and Drug Administration (FDA) has granted priority review for the label expansion of a kidney drug developed by Roche and Biogen.

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.

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.

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 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.

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.

The U.S. Food and Drug Administration (FDA) is requesting public feedback on the process of repurposing existing drugs for new medical indications.

Nuvation's application to expand the label for its drug Ibtrozi is currently undergoing review by the U.S. Food and Drug Administration (FDA).

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 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.

Arbutus Biopharma announced that its lead drug candidate has received Fast Track designation from the U.S. Food and Drug Administration (FDA).

Boston Scientific has announced that its Asurys Fluid Management System has received clearance 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.

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

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 U.S. Food and Drug Administration (FDA) has proposed changes to regulations that would require food manufacturers to notify the agency before introducing new ingredients or additives.

The U.S. Food and Drug Administration (FDA) has approved Lipfendra, a novel pill designed to help manage cholesterol levels.

The U.S. Food and Drug Administration (FDA) has accepted BioMarin's supplemental New Drug Application (sNDA) seeking full approval for its drug Voxzogo.

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.

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 U.S. Food and Drug Administration (FDA) has accepted Inhibrx's Biologics License Application (BLA) for ozekibart.

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.

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.

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.

Zai Lab announced that its cancer drug, zocilurtatug pelitecan, has been granted Fast Track status by the U.S. 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) has announced that testing confirms the safety of the domestic infant formula supply.

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).

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.

An article discusses the need for global health governance to reduce its reliance on the U.S. Food and Drug Administration (FDA).

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

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

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...

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.