FDA

Smith+Nephew Launched Hip Arthroplasty System in India  On August 17, 2023, The London-based orthopedic device maker Smith+Nephew announced the launch of its OR3O dual mobility system for use in primary and revision hip arthroplasty in India. The dual mobility implants have a smaller-diameter femoral hea...

Eylea HD Injection 8 Mg Approved By FDA for Treatment of Wet AMD, DME, and Diabetic Retinopathy The FDA has approved Regeneron Pharmaceuticals’ EYLEA HD (aflibercept) Injection of 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retin...

4WEB Medical Launched its Cervical Spine Plating Solution  On August 15, 2023, 4WEB Medical, an orthopedic implant company focused on developing innovative implants that utilize its proprietary Truss Implant Technology™, launched the newest addition to the company's implant portfolio, the Cervical Spine Pla...

FDA Clears J&J’s 2-in-1 Tablet for Prostate Cancer Johnson & Johnson's Janssen Pharmaceutical Companies stated that the US Food and Drug Administration (FDA) had approved AKEEGA (niraparib and abiraterone acetate), the first-and-only dual-action tablet combining a PARP inhibitor including abiraterone ace...

Quest Introduced First-To-Market Consumer-Initiated Blood Test for Alzheimer's Disease Risk Assessment on Questhealth Website On July 31, 2023, Quest Diagnostics, a leader in diagnostic information services, announced the introduction of the AD-Detect™ Test for Alzheimer's Disease on questhealth.com – the first ...

FDA Approves ZURZUVAE, the First and Only Oral Treatment Approved for Women with Postpartum Depression Biogen Inc. and Sage Therapeutics, Inc. announced that the FDA has approved ZURZUVAE (zuranolone) 50 mg for individuals with postpartum depression (PPD). ZURZUVAE is the first and only 14-day oral, once-daily t...

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...