Regulatory
The concern relates to the risk of two rare heart inflammation conditions, myocarditis and pericarditis, that have been linked to the Pfizer and Moderna mRNA vaccines.
The U.S. Food and Drug Administration has a few PDUFA dates on its calendar for this week. Here’s a look.
The advisory committee voted 19-0 to recommend the extra dose of the J&J shot for anyone 18 years and older.
According to CNN, Califf is being vetted by the administration of Joe Biden, who served as vice president to Obama.
Protagonist Therapeutics announced Monday morning that the FDA had removed the hold on PV drug candidate rusfertide, clearing the way for all trials to resume.
Two companies reported regulatory submissions to the FDA, and a third reported successful clinical trial data that will form the basis of submission in the coming months.
Acting FDA Commissioner Janet Woodcock’s days as interim head of the agency are numbered due to federal regulations. Speculations are rampant on a number of potential choices.
The U.S. FDA is kicking off the month of October with a number of PDUFA dates and an advisory committee meeting. Read on for more details.
Catalyst Pharmaceuticals received a positive decision from the 11th Circuit Court of Appeals over a suit against the U.S. FDA’s approval of a competitor’s amifampridine product.
The announcement came following independent FDA analyses of inspections conducted at the two CROs in November 2019.
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