Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer

SOFIE Biosciences doses first patient in Phase 3 trial of novel cancer imaging agent

The study will run across 18 sites and enroll roughly 200 patients over 24 months

US House passes Bill reauthorizing FDA rare disease incentive program

Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613

The therapy targets the LRRC15 protein and is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs.

Xeureka & UBE launch joint cancer drug discovery program

Xeureka will receive an upfront payment from UBE and will be eligible for milestone payments tied to future research progress

EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease

Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD

SandboxAQ, MapLight team up to target novel CNS therapy with AI-driven drug discovery

SandboxAQ will receive an upfront payment and could earn up to $200 million in milestone payments tied to preclinical, development, regulatory, and commercial achievements

$22 million BARDA project taps ProteoNic Tech to boost life-saving monoclonal antibody manufacturing

The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification

FDA nods spotlight precision oncology platforms as market surges towards $212 billion by 2034

The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034

Roche secures European nod for Gazyva/Gazyvaro in Lupus Nephritis patients

The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies