Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty

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

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 approves Bravecto Quantum from Merck Animal Health

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

Merck to acquire Verona Pharma for US$ 10 billion

Acquisition aligns with Merck’s science-led business development strategy and expands pipeline and portfolio of treatments for cardio-pulmonary diseases

Duke Street Bio receives FDA fast track designation for PARP1-selective inhibitor with CNS activity

Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need