Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms

SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally

The receipt of EIR reaffirms the company's commitment to maintaining global quality standards

Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL

Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments

FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025

Zydus receives final approval from USFDA for Celecoxib Capsules

Celecoxib is a nonsteroidal anti-inflammatory drug

Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’

Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease

FDA accepts new drug application for Merck’s Doravirine/Islatravir

The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product