Tag: US FDA
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) for the treatment of a type of ... Read More
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 (chloroprocaine hydrochloride ophthalmic gel) 3% from the ... Read More
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 mg/ml, its generic for Revatio, from the ... Read More
Amylyx Pharmaceuticals gets RELYVRIO FDA approval for ALS
RELYVRIO FDA approval for ALS : Amylyx Pharmaceuticals has secured approval for RELYVRIO (sodium phenylbutyrate and taurursodiol) from the US Food and Drug Administration (FDA) ... Read More
Ayala Pharmaceuticals AL102 gets FDA fast track status in desmoid tumors
Ayala Pharmaceuticals has been granted fast track designation for its oral gamma-secretase inhibitor AL102 by the US Food and Drug Administration (FDA) for the treatment ... Read More
Zydus Lifesciences gets tentative FDA approval for Sugammadex generic
Zydus Lifesciences (previously Cadila Healthcare) said that its American subsidiary Zydus Pharmaceuticals (USA) has secured tentative approval for Sugammadex Injection USP 200 mg/2 mL (100 ... Read More
Centessa Pharmaceuticals gets FDA orphan drug status for SerpinPC in hemophilia B
Centessa Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for SerpinPC in hemophilia B treatment. According to the UK-based ... Read More
Zydus Lifesciences bags FDA approval for Cariprazine generic
Zydus Lifesciences (previously Cadila Healthcare) said that its American subsidiary — Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration ... Read More
US FDA issues Form 483 to Alkem Laboratories for St Louis plant
Alkem Laboratories said that it has been issued Form 483 with a couple of observations from the US Food and Drug Administration (FDA) pertaining to ... Read More
Granules India gets FDA approval for Loperamide Hydrochloride and Simethicone Tablets
Granules India has secured approval for its abbreviated new drug application (ANDA) for Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC) from the US ... Read More
