FDA releases the form FDA-483 with seven observations from an inspection at the Exton, PA-based ProRx outsourcing facility.
FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug that is also an unl...
In a recent interview, FDA commissioner Marty Makary positions himself as a supporter of vaccines while defending recent agency actions that have draw...
FDA commissioner Marty Makary says the agency has no plans to add a Black Box Warning to Covid vaccines, contradicting a report from last week saying ...
Vanda Pharmaceuticals files a BLA for imsidolimab and its use in treating generalized pustular psoriasis, a rare and potentially fatal inflammatory sk...
FDA proactively awards Johnson & Johnson a national priority voucher for teclistamab in combination with daratumumab for treating relapsed or refracto...
Sanofi says it will not seek FDA approval for tolebrutinib in primary progressive multiple sclerosis after the drug failed to meet its primary endpoin...
FDA says it is removing a long-standing barrier to the use of real-world evidence in regulatory reviews by accepting such data without requiring ident...
