recent pharma news

FDA 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...

GSK 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'...

FDA 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...

Lexicon 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...

FDA 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...

FDA 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...

FDA 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 ...

Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) had granted marketing authorization for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form...

RegeneRx Biopharmaceuticals Enrolled First Patient in the Phase 3 Neurotrophic Keratitis Clinical Trial with RGN-259 in the US On April 12, 2023, RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or "Company") announced that the first patient of Phase 3 clinical trial (SEER-2) of RGN-259, a novel treat...

Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm On March 21, 2023, Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, announced it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to ...