FDA Seeks Feedback on Repurposing Drugs
The U.S. Food and Drug Administration (FDA) is requesting public feedback on the process of repurposing existing drugs for new medical indications.
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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 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.
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.
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.
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 stated that Amgen's drug Tavneos has been 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).