Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU

Sanofi flags delay in FDA review of Tolebrutinib for progressive multiple sclerosis

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia

Alphyn Biologics bags $25 million financing to advance breakthrough skin disease therapies

Alphyn is developing Zabalafin Hydrogel as the first therapy to simultaneously tackle the interconnected drivers of AD

Formation Bio snaps up global rights to next-gen CNS TYK2 inhibitor from Lynk Pharma

LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure

Cipla launches Yurpeak (tirzepatide) for the treatment of obesity and type 2 diabetes in India

Tirzepatide is the first and only dual agonist glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors

Denali clinches $275 million royalty deal to power potential breakthrough Hunter Syndrome therapy

Debiopharm launches pivotal phase III trial for novel quarterly acromegaly treatment

Acromegaly, a rare chronic endocrine disorder caused by excess growth hormone, is seeing promising advances in treatment development

Bayer reports promising results for low-dose pediatric MRI contrast agent

MRI is particularly valuable in pediatric care due to its non-invasive nature

Merck Animal Health wins FDA’s fast-track green light for first-in-decades cattle parasite treatment

The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation