Tag: US FDA

Cue Biopharma gets FDA fast track status for CUE-101 in HPV16+ R/M HNSCC

businessnewstoday- October 5, 2022

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

businessnewstoday- October 2, 2022

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

businessnewstoday- October 2, 2022

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

businessnewstoday- October 1, 2022

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

businessnewstoday- September 29, 2022

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

- September 18, 2022

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

- September 17, 2022

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

- September 17, 2022

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

- September 16, 2022

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

- August 30, 2022

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