Browsing Tag
US Food and Drug Administration
333 posts
FDA indicates official action on Jubilant Pharmova Roorkee facility
Jubilant Pharmova said that the US Food and Drug Administration (FDA) has determined the inspection classification of its…
FDA approves Janssen’s TECVAYLI for multiple myeloma treatment
The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced the US Food and Drug Administration’s approval…
Zydus Lifesciences gets FDA final approval for Micafungin for Injection
Zydus Lifesciences (formerly Cadila Healthcare) has secured final approval for Micafungin for Injection, 50 mg/vial and 100 mg/vial,…
Alembic Pharmaceuticals clears US FDA inspection at Vadodara bioequivalence facility without observations
Alembic Pharmaceuticals clears US FDA inspection at Vadodara bioequivalence facility with zero observations, strengthening its generics pipeline and regulatory track record.
Zydus Lifesciences gets FDA final approval for Toradol generic
Zydus Lifesciences Limited (previously Cadila Healthcare Limited) has secured final approval for its analgesic drug Ketorolac Tromethamine Tablets…
AbbVie bags RINVOQ FDA approval for nr-axSpA in adults
RINVOQ FDA approval for nr-axSpA : AbbVie has bagged approval for its selective JAK inhibitor RINVOQ (upadacitinib 15…
Vanda Pharmaceuticals gets FDA orphan drug status for VPO-227 in cholera
Vanda Pharmaceuticals has secured orphan drug designation for VPO-227 from the US Food and Drug Administration (FDA) for…
Zydus Lifesciences gets FDA tentative approval for Valbenazine Capsules
Zydus Lifesciences (previously called Cadila Healthcare) said that its subsidiary Zydus Worldwide DMCC has been given tentative approval…
Can Unichem Laboratories’ FDA approval for generic Dilantin boost its US epilepsy drug portfolio?
Unichem Laboratories wins US FDA approval for its generic Dilantin capsules to treat seizures, expanding its US neurology portfolio.
Biomea Fusion to take BMF-219 into clinical trials for KRAS solid tumors
Biomea Fusion is all set to take BMF-219 into clinical trials in patients having unresectable, locally advanced, or…