BioMarin’s Roctavian US Launch: Focus on Commercial Strategy Amid EU Failures, Analyst Points Out
On Thursday, The FDA approved BioMarin Pharmaceutical Inc's (NASDAQ: BMRN) Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for adults
LumiraDx Submits First 510(k) Application To The FDA For COVID Ultra Test
LumiraDx Limited (NASDAQ:LMDX), a leading innovator in diagnostic technologies, today announced the submission of its first 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its
Alnylam Announces Date Of Planned FDA Advisory Committee Meeting As Of September 13, 2023 For ONPATTRO For The Treatment Of The Cardiomyopathy Of ATTR Amyloidosis
Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has set a date of September 13, 2023 for the meeting of the
Why Are Unicycive Therapeutics Shares Trading Lower Today
Unicycive Therapeutics Inc (NASDAQ: UNCY) provided an update based on recent interactions with the FDA concerning the company's New Drug Application (NDA) for lanthanum dioxycarbonate (LDC),
Why Renalytix Stock Is Surging Today
Renalytix plc (NASDAQ: RNLX) shares are gaining after the FDA granted De Novo marketing authorization for its KidneyIntelX.dkd prognostic test to assess the risk of progressive kidney function decline in adults with diabetes and
BioMarin’s Delayed Roctavian Scores FDA Nod As First Hemophilia A Gene Therapy In US
The FDA approved BioMarin Pharmaceutical Inc's (NASDAQ: BMRN) Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to
Madrigal Pharmaceuticals Announces Rolling Submission Of New Drug Application To U.S. FDA Seeking Accelerated Approval Of Resmetirom For The Treatment Of NASH With Liver Fibrosis
Madrigal expects to complete full submission of the New Drug Application in July 2023
CONSHOHOCKEN, Pa., June 30, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage
Cyclo Therapeutics Announces Publication Of Data From Phase 2 Clinical Study Of Trappsol Cyclo For The Treatment Of Niemann-Pick Disease Type C1
– Data published in official journal of Molecular Genetics and Metabolism Reports:
Evidence of a change in cholesterol homeostasis in peripheral organs and the brain after the initial
Akebia Therapeutics Announces Top-Line Results Of Phase 4 IMPACT Study Of Auryxia For In-Center And Home Dialysis Patients
Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced topline results from IMPACT, a Phase 4 collaborative
BetterLife Fast Tracks Its US Patent For Non-Hallucinogenic Compound And Other LSD Derivatives
Psychedelics biotech BetterLife Pharma Inc. (OTCQB: BETRF) is fast-tracking its U.S.