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

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.

FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels

Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access