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Category: FDA


FDA, Regulations

FDA suspends US testing of Sarepta Duchenne drug over safety concerns

June 23, 2022

Via: Biopharma Dive

Sarepta is known for several RNA-based medicines that it’s brought to market for Duchenne muscular dystrophy, each of which help patients produce a shortened form of the muscle-protecting protein they would otherwise lack. But the drugs only produce small amounts […]


FDA, Regulations

FDA User Fee Legislation Advances in Senate

June 17, 2022

Via: Biopharm International

A broad bill carrying multiple proposals for revising and expanding FDA programs and policies, in addition to reauthorizing user fees critical for funding FDA operations, was endorsed by the Senate Health, Education, Labor and Pensions (HELP) Committee this week. The […]


FDA, Regulations

FDA Approves First Pill to Treat Severe Alopecia

June 14, 2022

Via: Drugs.com

The first pill to treat adults with severe alopecia was approved by the U.S. Food and Drug Administration on Monday. Olumiant (baricitinib) is the first FDA-approved alopecia therapy that treats the entire body rather than a specific spot, the agency […]


FDA, Regulations

FDA approves first systemic treatment for alopecia areata

June 13, 2022

Via: World Pharma News

Today, the U.S. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year. Today’s […]


FDA, Regulations

FDA Advisors Back Novavax COVID Shot

June 8, 2022

Via: Drugs.com

A U.S. Food and Drug Administration vaccine advisory panel on Tuesday recommended that Novavax’s COVID-19 shots be added to the vaccine arsenal that Americans have at their disposal. Twenty-one panel members voted to approve the vaccine, while one person abstained. […]


FDA, Regulations

FDA extends review of Amylyx ALS drug, delaying approval decision

June 3, 2022

Via: Biopharma Dive

The FDA doesn’t disclose its rationale for extending drug reviews and Amylyx’s statement on the delay offered few details, making it hard to tell how the agency views the company’s application. Two months ago, expert advisers convened by the FDA […]


FDA, Regulations

FDA Approves Fylnetra (pegfilgrastim-pbbk), a Biosimilar to Neulasta

May 27, 2022

Via: Drugs.com

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Biologics License Application (“BLA”) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the […]


FDA, Regulations

FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain

May 19, 2022

Via: World Pharma News

Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the […]


FDA, Regulations

FDA has change of heart, plans to convene advisory meeting for Cytokinetics’ cardiac med

May 17, 2022

Via: FierceBiotech

The FDA will convene an advisory committee to discuss Cytokinetics inconsistent heart failure med after all, more than three months after the agency first indicated it would not. A date or topic list for the meeting has not yet been […]


FDA, Regulations

FDA Expands Baby Formula Market to Foreign Suppliers, Moves to Reopen Abbot Plant

May 16, 2022

Via: Drugs.com

Dealing with a crippling shortage of infant formula that has many U.S. parents desperate, the Food and Drug Administration on Monday announced ‘Increased flexibilities” in allowing foreign manufacturers to help boost American supply of the vital product. Also on Monday, […]


FDA, Regulations

FDA Approves Radicava ORS (edaravone) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

May 13, 2022

Via: Drugs.com

Mitsubishi Tanabe Pharma Corporation (MTPA) today announced the U.S. Food and Drug Administration (FDA) has approved Radicava ORS (edaravone), the oral form of edaravone, for the treatment of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease that currently has no cure […]


FDA, Regulations

Company Hid Problems With COVID Vaccines From FDA

May 10, 2022

Via: Drugs.com

Evidence of quality control problems was hidden by a company contracted by the U.S. government to produce hundreds of millions of COVID vaccine doses, a new House committee report shows. It noted that Emergent BioSolutions didn’t disclose the issues at […]