Pfizer’s ($PFE) TALZENNA and XTANDI Combo Accepted for FDA Review
Pfizer Inc. (NYSE: PFE) has announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application for Priority Review...
FDA Greenlights Atrium Therapeutics’ ($RNA) Corventis™ Trial
Atrium Therapeutics, Inc. (NASDAQ: RNA) has received approval from the U.S. Food and Drug Administration for its Investigational New Drug application, allowing the company...
FDA Accepts BioMarin’s ($BMRN) VOXZOGO sNDA for Review
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for...
Bristol Myers Squibb ($BMY) Secures FDA Review Date For Mezigdomide NDA
Bristol Myers Squibb (NYSE: BMY) has received acceptance from the U.S. Food and Drug Administration for its New Drug Application for mezigdomide. This drug,...
Agios Pharmaceuticals ($AGIO) Receives FDA Priority Review for Mitapivat
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) has received acceptance from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for...
Organogenesis ($ORGO) ReNu® BLA Secures FDA Review Date
Organogenesis Holdings Inc. (NASDAQ: ORGO) has announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for ReNu®,...
AbbVie ($ABBV) Wins EC Approval for TEPKINLY Combination in Follicular Lymphoma
AbbVie (NYSE: ABBV) has received marketing authorization from the European Commission for TEPKINLY® (epcoritamab) in combination with lenalidomide and rituximab for treating adult patients...
Pharvaris ($PHVS) Deucrictibant NDA Accepted by FDA for Review in HAE
Pharvaris (NASDAQ: PHVS) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application for deucrictibant immediate-release capsules (20...
AtaiBeckley ($ATAI) Completes Dosing in VLS-01 Phase 2b Trial
AtaiBeckley Inc. (NASDAQ: ATAI) has completed dosing the last patient in its Elumina Phase 2b clinical trial, which evaluates VLS-01 for treatment-resistant depression (TRD).
This...
Vertex Pharmaceuticals ($VRTX) Gains FDA Approval for Expanded CASGEVY Use
Vertex Pharmaceuticals (NASDAQ: VRTX) has received approval from the U.S. Food and Drug Administration for the expanded use of its genetic therapy, CASGEVY® (exagamglogene...