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Results For "US-FDA"

342 News Found

Roche launches first rapid point-of-care test for whooping cough
News | December 04, 2025

Roche launches first rapid point-of-care test for whooping cough

The PCR-based test, delivered via Roche’s cobas liat system, allows results to be obtained during a patient consultation in GP practices and Emergency Rooms


FDA nod to priority review to AstraZeneca’s Baxdrostat for hard-to-control hypertension
Drug Approval | December 04, 2025

FDA nod to priority review to AstraZeneca’s Baxdrostat for hard-to-control hypertension

Here's a development that aims to keep your blood pressure in check. Literally!


Cleveland Diagnostics’ IsoPSA test for prostate cancer detection gains FDA approval
News | December 03, 2025

Cleveland Diagnostics’ IsoPSA test for prostate cancer detection gains FDA approval

Now a test that offers new precision in prostate cancer detection


FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich
Drug Approval | December 02, 2025

FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA


a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system
News | November 30, 2025

a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system

Abdomen-pelvis CT is the nation’s highest-volume CT category


SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine
Drug Approval | November 27, 2025

SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine

The approval by the US FDA comes after extensive safety testing and manufacturing improvements


Transmural Systems wins breakthrough FDA nod for coronary-saving TAVR device
Medical Device | November 27, 2025

Transmural Systems wins breakthrough FDA nod for coronary-saving TAVR device

The clearance for TELLTALE positions Transmural Systems at the forefront of next-generation electrosurgical solutions for structural heart interventions


FDA updates label for Sun Pharma’s UNLOXCYT, highlighting durable responses in advanced skin cancer
Clinical Trials | November 27, 2025

FDA updates label for Sun Pharma’s UNLOXCYT, highlighting durable responses in advanced skin cancer

The update reflects long-term clinical trial data showing that many patients with mCSCC or laCSCC experienced lasting responses


Glenmark Pharma gets VAI from FDA for Monroe facility
Drug Approval | November 27, 2025

Glenmark Pharma gets VAI from FDA for Monroe facility

The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site