[ Price : $8.95]
Four stakeholder companies suggest changes to an FDA draft guidance on cross labeling oncology drugs in combination regimens.[ Price : $8.95]
FDA warns Chinas Yuyao Yijia Daily Chemical Co. about CGMP violations in its manufacturing of OTC drugs.[ Price : $8.95]
FDA accepts for priority review a Vertex Pharmaceuticals supplemental NDA to expand the use of Trikafta (elexacaftor/tezacaftor/iv...[ Price : $8.95]
Myovant Sciences and Pfizer report positive data from the Phase 3 SPIRIT long-term extension study involving relugolix combination...[ Price : $8.95]
FDA publishes a list of 105 proposed new and revised draft guidances to be issued by CDER in 2021.[ Price : $8.95]
FDA places all alcohol-based hand sanitizers from Mexico on import alert to intercept them until the agency is able to review thei...[ Price : $8.95]
FDA releases the FDA-483 with eight inspection observations issued to CareFusion 303.[ Price : $8.95]
FDA says Edge Pharma is illegally marketing its mixtures of allergenic extracts for allergy treatment.