Merck’s experimental cancer drug wins FDA breakthrough status in key lung cancer setting

The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial

Lilly posts strong early clinical results for one-shot gene-editing cholesterol therapy

A one-shot gene-editing cholesterol therapy could soon be a reality

SN Bioscience doses first patient in global trial of experimental drug for aggressive lung cancer

The drug also delivered a disease control rate (DCR) of 83.3% in high-dose cohorts and a mean progression-free survival of 6.3 months in SCLC patients

Revvity wins FDA clearance for total testosterone test

Actio Biosciences launches Phase 1b/2 trial for ultra-rare pediatric epilepsy therapy

The company also confirmed that ABS-1230 has been accepted into the U.S. Food and Drug Administration’s Rare Disease Evidence Principles (RDEP) process

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

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

Microbot Medical Inc. appoints Alon Tamir as VP Sales EMEA

Tamir brings more than 20 years of experience in the medical technology sector

Sun Pharma Advanced Research Company to sell priority review voucher for $195 Million

SPARC enters definitive agreement to monetise rare paediatric disease PRV, unlocking capital for R&D and strategic growth