Biologically Active Substance – Page 6

FDA Approves SpringWorks’ Gomekli for Adult and Pediatric NF1-PN Patients

2 months ago talkbio0Tagged Approved, Gomekli, Inhibitor, MEK, mirdametinib, neurofibroma, Plexiform, SpringWorks, United States Food and Drug Administration

Gomekli, mirdametinib, neurofibromatosis type 1, plexiform neurofibromas, FDA approval, SpringWorks Therapeutics, MEK inhibitor

FDA Issues Import Alerts for Two Chinese API Manufacturers Following Failed Inspections

2 months ago talkbio0Tagged alpha 1-antitrypsin, Chengdu, Chinese Language, Dosage Forms, Failed, import alert, innovation, Inspection (procedure), manufacturers, Quality, Science of Chemistry, United States Food and Drug Administration, Wuhu

FDA, import alert, Chinese API manufacturers, failed inspections, quality control, Wuhu Nuowei Chemistry, Chengdu Innovation Pharmaceutical

Novartis Acquires Anthos Therapeutics for $925M, Regaining Control of Promising Anticoagulant Abelacimab

2 months ago talkbio0Tagged abelacimab, Acquisition, Anthos, Anticoagulants, Atrial Fibrillation, cardiovascular pipeline, Cerebrovascular accident, Factor XI antibody, Novartis

Novartis, Anthos Therapeutics, acquisition, abelacimab, anticoagulant, Factor XI inhibitor, atrial fibrillation, stroke prevention, cardiovascular pipeline

Boehringer Ingelheim’s Nerandomilast Succeeds in Second Phase III Lung Fibrosis Trial, Paving Way for FDA Approval

2 months ago talkbio0Tagged Approved, Boehringer, FIBRONEER-ILD, fibrosing, Improvement, Ingelheim, Inhibitor, nerandomilast, PF-ILDs, Phase 3 Clinical Trials, phosphodiesterase 4B, Progressive, Respiratory physiology, United States Food and Drug Administration

Nerandomilast, Boehringer Ingelheim, Phase III trial, FIBRONEER-ILD, progressive fibrosing interstitial lung diseases (PF-ILDs), lung function improvement, FDA approval, phosphodiesterase 4B (PDE4B) inhibitor

Relmada Acquires Promising Tourette’s Syndrome Drug Candidate from Asarina Pharma

2 months ago talkbio0Tagged Acquisition, Asarina, asset, CNS disorder, Neurosteroids, Pharma, Phase 2b, Pregnanolone, (3beta, 5alpha)-isomer, Relmada, Tourette 's syndrome

Relmada Therapeutics, Asarina Pharma, Sepranolone, Tourette’s syndrome, neurosteroid, Phase 2b, asset acquisition, CNS disorders

DOGE Access to Treasury Systems Restricted Amid Concerns Over CMS Scrutiny

3 months ago talkbio0Tagged concerns, DOGE, Elon, federal, Musk secretion from Musk Deer, Myasthenic Syndromes, Congenital, Patient location type - Department, payment, Privacy

Elon Musk, DOGE, Treasury Department, CMS, payment systems, privacy concerns, lawsuit, federal court order

Turnstone Biologics Discontinues Final Clinical Program, Initiates Strategic Review Amid Financial Constraints

3 months ago talkbio0Tagged Arenaria, Biological Factors, clinical program, Discontinuation (procedure), Financial cost, Industry, Lymphocytes, Tumor-Infiltrating, Manufacturing, strategic alternatives, TIDAL-01

Turnstone Biologics, TIDAL-01, clinical program discontinuation, layoffs, strategic alternatives, TIL therapy, manufacturing costs, biotech industry challenges