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

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility

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

AB Science receives FDA and EMA authorization for phase 3 Trial of prostate cancer treatment

Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments

atai and Beckley Psytech announce positive Phase 2b results for treatment-resistant depression

atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design.