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 ...
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 ...
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 ...
Strongbridge Biopharma Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for RECORLEV® for the Treatment of Endogenous Cushing’s Syndrome
FDA has accepted the filing of the RECORLEV® (levoketoconazole) New Drug Application. Strongbridge Biopharma believes that this decision reflects the extensive clinical evidence in the NDA submissio ...
FDA Grants Orphan Drug Designation to HM15211 for Idiopathic pulmonary fibrosis (IPF)
Hanmi Pharmaceutical's LAPS Triple Agonist (HM15211) has been designated an orphan drug to treat Idiopathic pulmonary fibrosis (IPF). Pulmonary fibrosis affects the interstitium, the lung tissue that ...
Praxis Precision Medicines Receives Orphan Designation for SCN8A development and epileptic encephalopathy
According to Praxis Precision Medicines, Inc., a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders (CNS) char ...