Browsing Tag
US FDA
379 posts
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,…
Zydus Lifesciences gets FDA approval for Adapalene and Benzoyl Peroxide Topical Gel
Zydus Lifesciences (previously Cadila Healthcare) said that it has secured final approval from the US Food and Drug…
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…
Strides Pharma Science gets FDA approval for Colchicine Tablets generic
Strides Pharma Science Limited said that its Singapore-based stepdown fully-owned subsidiary — Strides Pharma Global Pte. Limited has…
Harpoon Therapeutics gets FDA fast track status for HPN217 in RRMM
Harpoon Therapeutics has bagged fast track designation for HPN217 from the US Food and Drug Administration (FDA) for…
Pfizer gets FDA breakthrough status for RSVpreF RSV vaccine candidate
Pfizer has secured breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate — PF-06928316 (RSVpreF) from…
Lantheus gets FDA approval for drug manufacturing facility in Billerica
Lantheus Holdings has secured approval from the US Food and Drug Administration (FDA) for the supplemental drug application…
Agios Pharmaceuticals gets PYRUKYND FDA approval for hemolytic anemia
Agios Pharmaceuticals has secured approval for PYRUKYND (mitapivat) from the US Food and Drug Administration (FDA) for the…
Lupin Pharmaceuticals gets FDA approval for SOLOSEC sNDA
Lupin Pharmaceuticals has secured approval from the US Food and Drug Administration for its supplemental new drug application…