FDA

Genesis MedTech Announces FDA Breakthrough Device Designation for the J-Valve™ Transfemoral System Genesis MedTech, a leading medical device company, announced that the US Food and Drug Administration (FDA) has designated its J-ValveTM Transfemoral (TF) System as a Breakthrough Device. This innovative heart valv...

FDA Expands GSK’s Jemperli Approval for Endometrial Cancer GSK plc announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with mismatch repair deficient...

VARON Launched the Game-changer in the Field--New VP Series Portable Oxygen Concentrator On July 19, 2023, VARON, a leading oxygen concentrator manufacturer, announced the launch of a game-changer portable oxygen concentrator VP-2.  A new member of the VP series, VP-2 is incorporated with innovative tech...

Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases Eli Lilly & Company and Versanis Bio announced a definitive agreement for Lilly to acquire Versanis, a private clinical-stage biopharmaceutical firm focused on the discovery of novel medications for the treatment of cardiometab...

Astellas Announces FDA Grants Priority Review for Zolbetuximab Biologics License Application Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the company's Biologics Licence Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-target...

Enovis completed the acquisition of Novastep On June 29, 2023, Enovis, one of the largest orthopedic device companies in the world, announced that the company had completed the purchase of Novastep and its foot and ankle minimally invasive surgical (MIS) platform, which was first announced in April 2023.  ...

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...

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...

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...

FDA 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...