FDA Grants Orphan Drug Designation to Revolutionary Cystic Fibrosis Therapy
Porosome Therapeutics, Inc. announced the Orphan Drug Designation of its cystic fibrosis therapy by the Food and Drug Administration (FDA).
Teva, Medincell announce FDA acceptance of sNDA for Uzedy
Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Medincell announced that the supplemental New Drug ...
Cure Today14h
FDA Accepts NDA For Dordaviprone in H3 K27M-Mutant Diffuse Glioma
A New Drug Application has been accepted seeking accelerated approval for dordaviprone for patients with recurrent H3 ...
FDA accepts Teva's application for Uzedy for bipolar I disorder
The FDA has accepted a supplemental New Drug Application submitted by Teva (NYSE:TEVA) and Medincell (OTC:MDCLF) for Uzedy ...
Investing15h
FDA accepts Teva, Medincell's supplemental application for UZEDY as bipolar I disorder treatment
UZEDY is currently approved for use every one or two months as a subcutaneous long-acting injectable (LAI) for the treatment ...
FDA accepts Teva & Medincell’s UZEDY sNDA for extended-release to treat BP-I
Teva Pharmaceuticals (TEVA) and Medincell (MEDCL) announced that the supplemental New Drug Application sNDA for UZEDY extended-release ...
Drug compounders sue over weight loss drugs’ removal from FDA shortage list
A trade group representing compounding pharmacies has filed a lawsuit against the Food and Drug Administration (FDA) for ...
Cure Today16h
FDA Accepts Priority Review for Pre- and Postsurgical Keytruda in HNSCC
The FDA accepted for priority review a supplemental Biologics License Application for Keytruda for resectable locally ...
Hosted on MSN16h
Gilead’s lenacapavir applications for HIV gain EMA validation
Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of ...
manilatimes23h
Clene and APST Enter Into an Agreement to Support FDA's Recommendation for Long-Term NfL Biomarker Analyses of CNM-Au8®'s Impact on NfL Reduction
Longitudinal ALS patient data from APST Research will enable a more robust analysis of the effect of CNM-Au8 on NfL biomarkers; APST Research data includes thousands of people liv ...