Lupin receives EIR from FDA for its Aurangabad facility

The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.

Novartis opens radioligand therapy manufacturing facility in California

New site expands manufacturing footprint to meet future demand; ensures continued on-time delivery rate of >99.9% to patients across western US, Alaska and Hawaii

Shilpa Medicare announces positive Phase 3 results for Oeris

OERIS offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days

FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma

Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition

Trump clinches historic deal as Lilly, Novo slash U.S. weight-loss drug prices

Agreements mark a major victory in the President’s long-term pledge to lower prescription drug costs for Americans

Nitinotes secures CE mark for automated suturing platform ‘EndoZip’

Enabling a new era in minimally invasive obesity treatment across Europe

Johnson & Johnson gets FDA nod for new depression treatment

This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials

Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer

Relmada expects to initiate its Phase 3 program in the first half of 2026

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases

MSD secures $700 million boost from Blackstone to advance broad-cancer ADC therapy Sac-TMT