Browsing Tag
US FDA
379 posts
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…
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.
Lilly gets FDA fast track designation for tirzepatide in obesity
Eli Lilly and Company (Lilly) has been granted fast track designation for tirzepatide from the US Food and…
Zydus Lifesciences gets FDA final approval for Brivaracetam generic
Zydus Lifesciences (previously Cadila Healthcare) said that its US subsidiary Zydus Pharmaceuticals (USA) has bagged final approval to…
Cue Biopharma gets FDA fast track status for CUE-101 in HPV16+ R/M HNSCC
Cue Biopharma has been granted fast track designation for CUE-101 from the US Food and Drug Administration (FDA)…
Harrow Health announces IHEEZO FDA approval for ocular surface anesthesia
IHEEZO FDA approval : Harrow Health, a Nasdaq-listed eyecare pharmaceutical company, and Sintetica have secured approval for IHEEZO…
Zydus Lifesciences wins final FDA approval for pulmonary hypertension drug
Zydus Lifesciences Limited (previously Cadila Healthcare Limited) has bagged final approval for Sildenafil for Oral Suspension USP 10…