FDA Approves First Gene Therapy for Severe Hemophilia A BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, announced that the US Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the tr...
Find MoreFDA Approves Jardiance for the Treatment of Type 2 Diabetes in Children 10 Years and Older Boehringer Ingelheim and Eli Lilly and Company announced that the FDA has approved Jardiance® (empagliflozin) 10 mg and 25 mg tablets to decrease blood sugar together with diet and exercise in children 10 years and older w...
Find MoreGSK Announces Extension of FDA Review Period for Momelotinib After all, GSK will not hear from the FDA this month about its marketing application for momelotinib as a therapy for anemia in myelofibrosis patients. The pharmaceutical company announced that the US Food and Drug Administration has extended the drug'...
Find MoreFDA Grants Fast Track Status to KYV-101 for Refractory Lupus Nephritis Treatment Kyverna Therapeutics announced that the FDA has given Fast Track status to KYV-101, a treatment for patients suffering from resistant lupus nephritis (LN). KYV-101 is an innovative therapy that uses anti-CD19 chimeric antigen recept...
Find MoreFDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults Pfizer Inc. announced that the FDA has authorized ABRYSVO (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory...
Find MoreLexicon Announces FDA Approval of INPEFA (Sotagliflozin) For Treatment of Heart Failure Lexicon Pharmaceuticals, Inc. announced that the FDA has approved INPEFATM (sotagliflozin), a once-daily oral tablet, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure vis...
Find MoreFDA Approves RINVOQ as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease AbbVie announced that the FDA had approved RINVOQ® (upadacitinib) for treating people with moderately to highly active Crohn's disease who have had an unsatisfactory response or intolerance to one or more TNF blockers. Thi...
Find MoreSarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy Sarepta Therapeutics, Inc., a pioneer in precision genetic medicine for rare diseases, announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in favor of...
Find MoreFDA Approves GSK’s Arexvy, the First RSV Vaccine for Older Adults GSK plc stated that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in peopl...
Find MoreFDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking to expand the current indication of luspatercept-aamt (Reblozyl) to include treatment of anemia in patients with very ...
Find MoreThe American Society of Clinical Oncology (ASCO) is one of the largest and most respected conferences in the field of oncology. Held annually, this conference brings together researchers, physicians, and other healthcare professionals from around the world to discuss the latest advances in cancer research, diagnosis, and treatment.