USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI

The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.

Alto Neuroscience completes enrollment in Phase 2 trial for first-of-its-kind schizophrenia cognitive treatment

Alto met its enrollment goal with 83 patients across 13 US clinical sites

Irish medtech firm InVera Medical wins EU nod for breakthrough vein treatment device

Lyell Immunopharma launches groundbreaking Phase 3 CAR T-Cell trial for aggressive lymphoma

PiNACLE is a head-to-head study comparing its next-generation CAR T-cell therapy against established therapies liso-cel and axi-cel in patients with relapsed or refractory large B-cell lymphoma

Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough

If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US

Centivax launches first human trial of universal flu vaccine

Agilent’s PD-L1 test gains FDA nod for ovarian cancer

This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA

Torrent Pharmaceuticals posts Rs. 577 Cr Q3 profit; nine-month earnings jump to Rs. 1,725 Cr

NATCO receives CDSCO approval for Semaglutide in India

Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus

Zydus receives final approval from USFDA for Ammonium Lactate Cream, 12%