Four stakeholder companies suggest changes to an FDA draft guidance on cross labeling oncology drugs in combination regimens.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