QIAGEN bags FDA nod for full GI testing on QIAstat-Dx Rise system

The approval means US laboratories can now run both respiratory and gastrointestinal panels on the high-throughput QIAstat-Dx Rise

Zydus receives USFDA approval for cevimeline hydrochloride capsules

Cevimeline Hydrochloride Capsules 30mg are indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren’s syndrome.

Caplin Steriles gets USFDA approval for potassium phosphates injection

APL Healthcare’s Unit-IV classified as VAI by the USFDA

This inspection is now closed

Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA

Marks significant milestone for breakthrough biologic to treat rare blood cancers

FDA nod to LifeVac De Novo, paving for next-generation anti-choking device

The FDA classified LifeVac as a Class II medical device

FDA nod to first treatment for rare genetic brain disorder

The approval comes after a systematic review of published literature

FDA nod to Bristol Myers Squibb’s Sotyktu as new oral therapy for psoriatic arthritis

The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials

Mosaic Clinical Technologies’ AI breakthrough earns FDA “Breakthrough Device” designation

Cognita CXR leverages a proprietary vision-language model to analyze full chest X-ray studies and generate comprehensive preliminary findings

FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer

Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population