FDA Grants Priority Review for OPNT003 Nasal Nalmefene to Treat Opioid Overdose
The FDA has accepted for Priority Review the New Drug Application for Opiant Pharmaceutical's OPNT003, an intranasal formulation containing the high-affinity opioid antagonist nalmefene, for the treat ...
First Patient Enrolled in Phase 3 Trial of Abelacimab for High-Risk Atrial Fibrillation Patients
Anthos Therapeutics has enrolled the first patient in a Phase 3 study to evaluate the efficacy and safety of abelacimab in high-risk patients with atrial fibrillation deemed unsuitable for current ant ...
Evaxion has received FDA approval to move forward with a Phase 2b clinical study for EVX-01
Evaxion Biotech A/S, a clinical-stage biotech company, announced that the FDA had given the green light for their Phase 2b clinical trial of EVX-01. The Company submitted an IND and Fast Track applica ...
Legend Biotech Announces Acceptance of Ciltacabtagene Autoleucel (Cilta-Cel) NDA in China
Legend Biotech Corp. announced that China's National Medical Products Administration accepted its New Drug Application for ciltacabtagene autoleucel, a novel therapy to treat life-threatening diseases ...
EffRx Obtains Swiss Marketing Authorization for Bronchitol® in Cystic Fibrosis.
EffRx Pharmaceuticals SA, a commercial-stage company that commercializes niche and orphan medicines in Switzerland and Europe, announced today that Swissmedic had approved Bronchitol® (inhaled mannito ...
Bluebird bio Receives EC Approval for SKYSONA™ for Early Cerebral Adrenoleukodystrophy (CALD)
Bluebird bio, Inc. today announced that The European Commission (EC) had approved SKYSONA™ (elivaldogene autotemcel, Lenti-D™), one-time gene therapy for the treatment of early Cerebral Adrenoleukodys ...
BridgeBio Pharma announced FDA granted approval to Truseltiq for advanced Cholangiocarcinoma
The FDA granted accelerated approval to infigratinib for previously treated locally advanced or metastatic Cholangiocarcinoma harbors FGFR2 fusion or rearrangement. Infigratinib (Truseltiq; BridgeBio ...
FDA approves Apic Bio’s APB-102 for SOD1 Amyotrophic lateral sclerosis
Apic Bio, Inc. today announced that the US FDA had cleared its IND application for APB-102 to treat SOD1 Amyotrophic lateral sclerosis (ALS) – a common cause of familial ALS. APB-102 is a next-generat ...
Immunocore announces the dosing of the first patient for chronic Hepatitis B with the ImmTAV® bispecific molecule
Immunocore Holdings Plc today announces the dosing of the first patient in the first-in-human clinical trial of IMC- 109V to treat patients with chronic hepatitis B (HBV) infection. Wholly owned IMC-I ...
PharmaEssentia Resubmits Ropeginterferon alfa-2b-njft Application to the US FDA to Treat Polycythemia Vera (PV)
PharmaEssentia USA Corporation, a global biopharmaceutical innovator, leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced th ...