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 ...
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 ...
Larimar Therapeutics Announces Positive Topline Phase 1 Clinical Trial Data of CTI-1601 in Friedreich ataxia patients.
Larimar Therapeutics, Inc., a clinical-stage biotechnology company focused on developing treatments for Friedreich ataxia and other complex rare diseases, announced today topline data from its Phase 1 ...
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 ...