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 ...
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 ...
Targeted Oncology1d
FDA Clears IND Application for LTZ-301 in non-Hodgkin Lymphoma
The FDA cleared the investigational new drug application for LTZ-301, a first-in-class myeloid engager immunotherapy, with a ...
Business Wire1d
LTZ Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of First-in-Class Myeloid Engager Immunotherapy, LTZ-301
FDA clears LTZ's IND application to initiate trial of its myeloid engager immunotherapy to treat relapsed or refractory non-Hodgkin lymphoma.
emjreviews.com1d
EMA grants accelerated review to Gilead’s PrEP drug
The EMA is set to perform accelerated reviews of Gilead Sciences’ applications for its twice-yearly injectable for HIV ...