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FDA releases the form FDA-483 with seven observations from an inspection at the Exton, PA-based ProRx outsourcing facility.[ Price : $8.95]
FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug...[ Price : $8.95]
In a recent interview, FDA commissioner Marty Makary positions himself as a supporter of vaccines while defending recent agency ac...[ Price : $8.95]
FDA commissioner Marty Makary says the agency has no plans to add a Black Box Warning to Covid vaccines, contradicting a report fr...[ Price : $8.95]
Vanda Pharmaceuticals files a BLA for imsidolimab and its use in treating generalized pustular psoriasis, a rare and potentially f...[ Price : $8.95]
FDA proactively awards Johnson & Johnson a national priority voucher for teclistamab in combination with daratumumab for treating ...[ Price : $8.95]
Sanofi says it will not seek FDA approval for tolebrutinib in primary progressive multiple sclerosis after the drug failed to meet...[ Price : $8.95]
FDA says it is removing a long-standing barrier to the use of real-world evidence in regulatory reviews by accepting such data wit...