Orca Bio’s Orca-T FDA review extended to July 2026

Biogen bags FDA nod for high dose SPINRAZA in spinal muscular atrophy

The new regimen, delivering 50 mg/5 mL and 28 mg/5 mL doses, offers a higher concentration of the drug for both loading and maintenance phases

Lilly to acquire sleep drug biotech firm Centessa in $6.3 billion deal

The company’s broader OX2R portfolio includes clinical and preclinical assets with potential applications across neurological, neurodegenerative, and neuropsychiatric conditions

Agilent bags FDA nod for key cancer diagnostic

The FDA approval makes PD-L1 IHC 22C3 pharmDx the only companion diagnostic approved to detect tumors expressing PD-L1 in esophageal or GEJ carcinoma patients for KEYTRUDA treatmen

ENHERTU approved in China as first HER2-targeted ADC for early breast cancer

The decision is based on the phase 3 DESTINY-Breast11 trial

Teva hits major biosimilar milestones with FDA nod and regulatory filings

The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia

Wockhardt’s breakthrough antibiotic Zaynich wins key regulatory nod in India

Granules Life Sciences receives VAI Classification for Shamirpet facility

The inspection is now closed, and no regulatory action has been recommended

Rocket Pharma gets FDA nod for first pediatric gene therapy targeting severe LAD-I

The approval covers pediatric patients without a matched sibling donor for stem cell transplant

Philips launches game-changing interventional platform for cardiology

IntraSight Plus enables confident decision-making and better patient care,” Philips said, emphasizing efficiency, simplicity, and precision