The European Medicines Agency is set to decide whether to recommend EU marketing approval for 11 new medicines, including two ...

Novo is set to learn whether the European Medicines Agency’s human medicines committee will back its hemophilia A drug for EU ...

Pharmaceutical product valuation needs assumptions that include market share, compliance and diagnosis rates. These need to ...

Glenmark's Ryaltris has reached Brazil ahead of schedule, bringing the allergy nasal spray to what the firm describes as the ...

While celebrating the near half-trillion dollars in US savings achieved by using generics and biosimilars in 2025, the AAM’s ...

Medicare has finalized expanded coverage for TAVR, including certain asymptomatic patients with severe aortic stenosis, while ...

AstraZeneca and Daiichi Sankyo’s HER2-targeting ADC showed a PFS benefit in first-line treatment of HER2-mutant non-small ...

Strong PFS data and oral convenience may enable zipalertinib to compete against J&J’s bispecific Rybrevant in NSCLC patients ...

The US FDA approved the myostatin inhibitor Isembyld (apitegromab) on top of SMN-targeted therapies for spinal muscular ...

Sanofi will transition 20 mature medicines to German established products player Cheplapharm, including the off-patent blood ...

Mike Davis used his first public address as permanent CDER director to outline realigned incentives that will favor ...

Peerbridge plans to introduce its newly FDA-cleared second-generation Cor MDx patch for detecting heart arrythmias to health ...