Browsing Tag
US Food and Drug Administration
333 posts
Ikena Oncology gets FDA fast track designation for IK-930 in mesothelioma
Ikena Oncology has secured fast track designation for IK-930 from the US Food and Drug Administration in the…
Alkem Laboratories issued FDA Form 483 for St. Louis facility
Alkem Laboratories Limited said that it has been issued Form 483 from the US Food and Drug Administration…
Alembic Pharmaceuticals gets FDA approval for Dasatinib Tablets
Alembic Pharmaceuticals has secured tentative approval for the abbreviated new drug application (ANDA) of Dasatinib Tablets, 20 mg,…
Strides Pharma gets FDA approval for Ibuprofen oral suspension
Strides Pharma Science Limited said that its stepdown fully-owned subsidiary — Strides Pharma Global Pte. Limited, Singapore, has…
PDS Biotechnology gets FDA fast track status for PDS0101
PDS Biotechnology has secured fast track designation to its PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab) from the…
Dr. Reddy’s, Senores launch Ketorolac Tromethamine Tablets in US
Dr. Reddy’s Laboratories and its partner Senores Pharmaceuticals have launched Ketorolac Tromethamine Tablets USP, 10 mg, in the…
Glenmark Pharmaceuticals receives FDA Form 483 with 17 observations for North Carolina facility
Glenmark Pharmaceuticals, a global pharmaceutical company based in India, announced that it has been issued Form 483 with…
Can Glenmark Pharmaceuticals’ FDA approval for Enstilar Foam generic boost its U.S. dermatology footprint?
Glenmark Pharmaceuticals secures FDA approval for its generic version of Enstilar Foam, aiming to expand its U.S. dermatology market presence.
Zydus Lifesciences gets FDA approval for Bortezomib for Injection
Zydus Lifesciences (previously called Cadila Healthcare) said that it has secured final approval from the US Food and…
Dr. Reddy’s Labs launches Posaconazole Delayed-Release Tablets in US
Dr. Reddy’s Laboratories said that it has launched Posaconazole Delayed-Release Tablets, 100 mg, a triazole antifungal drug, in…