USFDA nod to citrate free high concentration formulation of biosimilar Hyrimoz injection: Sandoz Ruchika Sharma22 March 2023 1:45 PM ISTSandoz intends to launch the Hyrimoz citrate-free HCF in the US on July 1, 2023.
Sanofi Dupixent gets European Commission nod for children aged 6 months to 5 years old with severe atopic dermatitis Ruchika Sharma22 March 2023 12:45 PM ISTDupixent is an injection administered under the skin at different injection sites.
Lupin gets USFDA approval for generic equivalent of Rexulti Tablets Ruchika Sharma22 March 2023 11:45 AM ISTThis product would be manufactured at Lupin's Pithampur facility in India.
Zydus Lifesciences arm bags USFDA nod for ulcerative colitis drug Tofacitinib Ruchika Sharma22 March 2023 10:00 AM ISTTofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis and for the treatment of adult...
Gilead Sciences exercises option to license Nurix's investigational targeted protein degrader molecule NX-0479 Ruchika Sharma21 March 2023 5:22 PM ISTFoster City: Gilead Sciences, Inc. and Nurix Therapeutics, Inc., a clinical-stage biopharmaceutical company developing targeted protein...
Glenmark Pharma gets final USFDA nod for Schizophrenia drug Prochlorperazine Maleate Ruchika Sharma21 March 2023 4:00 PM ISTMumbai: Glenmark Pharmaceuticals Ltd. has announced that the company has received final approval from the United States Food & Drug Administration...
Granules India's step-down subsidiary completes USFDA audit with zero observations Ruchika Sharma21 March 2023 2:55 PM ISTHyderabad: Granules India has announced that Granules Consumer Health Inc., a stepdown subsidiary of the Company and a wholly owned subsidiary of...
BioNTech, OncoC4 collaborate to co-develop and commercialize novel checkpoint antibody in multiple solid tumor indications Ruchika Sharma21 March 2023 2:15 PM ISTUnder the terms of the agreement, OncoC4 will receive a $200 million upfront payment and is eligible to receive development, regulatory and commercial...
Concert Pharma Deuruxolitinib significantly improves scalp hair regrowth in Alopecia areata, reveals data Ruchika Sharma21 March 2023 1:15 PM ISTDeuruxolitinib is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2.
USFDA nod to Caplin Steriles Rocuronium Bromide Injection Ruchika Sharma21 March 2023 12:15 PM ISTMumbai: Pharma major Lupin Limited has announced that its alliance partner Caplin Steriles Limited has received final approval from the United States...
USFDA grants Orphan Drug Designation to Zydus's ZYIL1 for treatment of Cryopyrin Associated Periodic Syndrome Ruchika Sharma21 March 2023 11:29 AM ISTZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates.
Lupin alliance partner Caplin Steriles bags USFDA okay for Thiamine Hydrochloride Injection Ruchika Sharma20 March 2023 5:39 PM ISTMumbai: Pharma major Lupin Limited today announced that its alliance partner Caplin Steriles Limited has received final approval from the United...
