FDA clears Rivanna’s Accuro XV AI-powered 3D ultrasound system

The ultrasound-based AI imaging platform is designed to support rapid fracture detection and soft tissue injury assessment in emergency care settings

Moderna’s mRNA flu vaccine outperforms standard shot in Phase 3 trial

NEJM study shows strong protection across strains

Merck completes $5.8 billion acquisition of Terns Pharma

At the center of the deal is TERN-701, a drug recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for adults with Philadelphia chromosome-positive chronic myeloid leukemia

Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility

The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026

Caplin Steriles receives USFDA approval for Calcium Gluconate Injection

Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million

Lupin receives USFDA approval for generic Ravicti oral liquid

Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders

SetPoint Medical launches first-in-human MS pilot study using implanted nerve stimulation device

Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility

The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026

FDA advisory panel backs AstraZeneca prostate cancer combo in decisive vote

The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer

FDA renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win

The renewal covers two versions of the IQOS device and three HEETS tobacco variants