Tag: US Food and Drug Administration

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

Zydus Lifesciences gets final FDA approval for Mirabegron generic

businessnewstoday- October 4, 2022

Zydus Lifesciences (previously Cadila Healthcare) said that its US subsidiary Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) ... Read More

McDonald’s takes down its Irish i...
McDonald’s takes down its Irish insurance company in move to Bermuda

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

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 launches Revlimid generic – Lenalidomide Capsules in US

- September 20, 2022

Indian pharma company Zydus Lifesciences Limited, previously known as Cadila Healthcare Limited has launched Lenalidomide Capsules, a generic of Revlimid, in the US market. The ... 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