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The FDA’s Center for Drug Evaluation and Research (CDER) has issued draft guidance for industry on developing medicines that can be used for the treatment of celiac disease (CeD) along with a gluten-free diet. Read More
The Federal Trade Commission (FTC) is extending the public comment period by a month on a request for information centering on the business practices of pharmacy benefit managers (PBMs). Read More
The FDA intends to revoke Protagonist Therapeutics’ Breakthrough Therapy designation for rusfertide as a treatment for a rare blood cancer that causes bone marrow to produce excess red blood cells, the company said. Read More
A bipartisan group of lawmakers from both chambers sent letters to seven drugmakers urging them to seek FDA approval for over-the-counter (OTC) versions of their naloxone drugs. Read More
The FDA has extended by three months its review of Regeneron Pharmaceuticals’ Biologics License Application (BLA) for its antiviral drug REGEN-COV (casirivimab plus imdevimab) for full approval as a preventive treatment for COVID-19. Read More