Regulatory
The FDA has two PDUFA dates on its calendar this week, with two extra days slotted for an advisory committee meeting to evaluate drug applications from three companies.
The Sept. 30 deadline for Congress to reauthorize the FDA’s prescription drug user fee is looming, while advocates and detractors are debating the merits of the funding source.
The FDA is heading into fall with a few Prescription Drug User Fee Act (PDUFA) dates. Here’s a look at this week’s upcoming action.
Although it was a short week due to the Labor Day holiday, the FDA maintained a steady pace of business.
Wednesday evening, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 7-2 to recommend approval of Amylyx ALS candidate AMX0035.
The FDA removed the clinical hold on Sarepta’s investigational treatment for certain types of DMD after the company agreed to adjust its clinical trial protocols.
The FDA provided briefing documents ahead of Amylyx’s rare second adcomm for AMX0035, an investigational treatment for ALS. The regulator does not appear to be convinced.
The U.S. Food and Drug Administration had a busy week leading up to the Labor Day holiday. Here’s a look at the agency’s recent activities.
The FDA is keeping busy as summer winds down, with approvals, Orphan Drug Designations and other actions. Here’s what the agency has been up to this week.
The United States and China are reportedly close to an agreement that would allow the PCAOB to audit companies listed on the U.S. stock exchange, per the Wall Street Journal.
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