FDA endorses Relmada’s registrational strategy for bladder cancer therapy

Merck scores FDA nod for TGT drug Pimicotinib, promising new hope for patients

The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes

Bayer acquires Attralus’ cutting-edge cardiac amyloidosis imaging agents

The acquisition of AT-01 (124-Iodine-evuzamitide) and AT-05 (PAR-Peptide + technetium-99m) positions Bayer at the forefront of cardiac amyloidosis diagnostics

FDA nod to first-ever treatment for fatal pediatric Menkes disease

4Moving Biotech bags FDA nod to launch US trial of groundbreaking osteoarthritis therapy

Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function

FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning

Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera

Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories

BeOne Medicines wins first-in-world nod for Sonrotoclax in China

The approval is backed by data showing deep, durable responses and manageable tolerability

GSK secures European nod for easier-to-use Shingrix prefilled syringe

The current two-vial format requires healthcare professionals to mix a lyophilised antigen with a liquid adjuvant before administration

GSK’s Exdensur wins Japanese nod for severe asthma

The approval follows robust data from the SWIFT and ANCHOR Phase III trials