Browsing Tag
US Food and Drug Administration
348 posts
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…
BriaCell Therapeutics’ Bria-IMT gets FDA fast track status in breast cancer
BriaCell Therapeutics has secured the fast track status from the US Food and Drug Administration (FDA) for its…
Axsome Therapeutics to acquire Sunosi from Jazz Pharmaceuticals
Axsome Therapeutics has agreed to acquire Sunosi (solriamfetol), an approved dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), from…
Pfizer RSVpreF vaccine candidate gets another FDA breakthrough therapy status
Pfizer said that PF-06928316 (RSVpreF), its respiratory syncytial virus (RSV) vaccine candidate, has been granted breakthrough therapy designation…
FDA rejects Lilly’s sintilimab as first line treatment of NSCLC
The US Food and Drug Administration (FDA) has rejected the biologics license application (BLA) of Eli Lilly and…
FDA refuses to approve AstraZeneca’s sBLA for Fasenra in CRSwNP
The US Food and Drug Administration (FDA) has refused to approve the supplemental biologics license application (sBLA) of…