GSK signs $745 million licensing agreement with Empirico for novel respiratory siRNA therapy

The deal reinforces GSK’s leadership in respiratory care and builds upon the company’s expanding COPD portfolio

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study

Biocon gets 1 USFDA observation for Cranbury site

The Cranbury facility represents a strategic advancement of the company's operations in the Unted States

Alembic Pharmaceuticals receives EIR for API - I and API - II facility located at Panelav

The inspection was carried out between May 26, 2025 and May 31, 2025

Briefs: Alembic Pharmaceuticals and Tyche Industries

Alembic receives EIR from USFDA for facility at Panelav

FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia

ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life

Novo Nordisk's Wegovy approved in the US for the treatment of MASH

The accelerated approval is supported by results from part 1 of the ESSENCE trial

Sanofi’s GPRC5D monoclonal antibody earns ODD in US for multiple myeloma

Roche updates on sBLA for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA