Briefs: IOL Chemicals & Pharmaceuticals, Ipca Laboratories and Anuh Pharma

Ipca Laboratories receives three observations from USFDA for API facility at Tarapur

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

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

Now a test that offers new precision in prostate cancer detection

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

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

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

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

FDA nod to AstraZeneca’s Imfinzi plus FLOT chemotherapy for early and locally advanced gastric cancer

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