AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)

FDA launches PreCheck program to bring drug manufacturing back to US

The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites

Sanofi’s Amlitelimab delivers in Phase 3 trials, heads for global filings

In the SHORE phase 3 study, amlitelimab, used in combination with topical therapies, met all primary and key secondary endpoints at Week 24

Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator

This marks the second indication for which gumokimab has gained NDA review acceptance

Lupin and Galenicum ink license and supply agreement for semaglutide in 23 countries

Galenicum will oversee development, manufacturing and supply, while Lupin will handle regulatory submissions, approvals, and commercialization and distribution of Semaglutide across 23 countries globally

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

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

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

Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy

The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production

FibroBiologics moves experimental psoriasis therapy into FDA review

The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline