A New Drug Application has been accepted seeking accelerated approval for dordaviprone for patients with recurrent H3 ...
The FDA has accepted a supplemental New Drug Application submitted by Teva (NYSE:TEVA) and Medincell (OTC:MDCLF) for Uzedy ...
Teva Pharmaceuticals (TEVA) and Medincell (MEDCL) announced that the supplemental New Drug Application sNDA for UZEDY extended-release ...
The FDA accepted for priority review a supplemental Biologics License Application for Keytruda for resectable locally ...
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Hosted on MSNGilead’s lenacapavir applications for HIV gain EMA validationGilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of ...
Adial Pharmaceuticals (ADIL) announced a “positive” response from the U.S. FDA regarding its proposed in vitro bridging strategy for AD04. The ...
The FDA cleared the investigational new drug application for LTZ-301, a first-in-class myeloid engager immunotherapy, with a ...
FDA clears LTZ's IND application to initiate trial of its myeloid engager immunotherapy to treat relapsed or refractory non-Hodgkin lymphoma.
Last week, the lobbying group AdvaMed pushed back on the firings, calling on Health Secretary Robert F. Kennedy Jr. to ...
The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has ...
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The FDA has accepted a priority review of a new biannual HIV prevention injection, with a decision expected by June 19, 2025.
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