We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has finalized its guidance on oral drug bioavailability (BA) studies, outlining its current recommendations for study designs, alternative approaches and other areas. 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
A new draft guidance from the FDA calls on sponsors to submit detailed plans for achieving racial/ethnic diversity in their trials as part of their investigational new drug (IND) or investigational device exemption (IDE) applications. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) yesterday released a Manual of Policies and Procedures (MAPP) document that spells out how the Office of Generic Drugs (OGD) will classify complex new drug products and drug-device combination products assigned to CDER. Read More
GlaxoSmithKline is buying Sierra Oncology and its investigational cancer drug momelotinib in a $1.9 billion windfall for the San Mateo, Calif.- based biopharmaceutical company. Read More