Hosted on MSN3d
Celltrion’s Avtozma receives FDA approval for multiple conditions
The FDA's approval is grounded in an evidence totality and comprehensive data package, which includes outcomes from a study.
Healio3d
FDA receives biologics license application for apitegromab in spinal muscular atrophy
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
US FDA approves Novo Nordisk's Ozempic to cut risk of diabetic kidney disease progression
The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as ...
EconoTimes9d
FDA Approves Ozempic for Kidney and Heart Protection in Diabetic Patients
The U.S. Food and Drug Administration (FDA) has approved Novo Nordisks (NYSE:NVO) Ozempic for reducing the risk of kidney ...
GlobalData on MSN8d
FDA gives RMAT designation to Beacon’s retinitis pigmentosa treatment
The FDA has granted RMAT designation to Beacon Therapeutics’ gene therapy, laru-zova, for treating X-linked retinitis ...
ophthalmologytimes3d
CHMP of the European Medicines Agency issues positive opinion on 2 aflibercept biosimilars
The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...
FDA Approves Once-Every-Four-Weeks Maintenance Dosing Of LEQEMBI For Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced Sunday that the U.S. Food and Drug Administration has approved the ...
Biogen, Eisai Get FDA Nod for Leqembi IV Maintenance Dosing
Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA ...
Pharmabiz5d
Celltrion’s Avtozma, a biosimilar to Actemra receives US FDA approval to treat RA, GCA, pJIA, sJIA and Covid-19
Jersey City, New Jersey Saturday, February 1, 2025, 16:00 Hrs [IST] ...
GlobalData on MSN8d
Novo Nordisk secures FDA approval for Ozempic in diabetes with CKD
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide) to reduce certain risks ...
MM&M10d
Biogen, Eisai receive FDA nod for monthly Leqembi IV maintenance dosing
The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.