Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA

Marks significant milestone for breakthrough biologic to treat rare blood cancers

FDA nod to first treatment for rare genetic brain disorder

The approval comes after a systematic review of published literature

Sumitomo Pharma bags world-first go-ahead for iPS cell therapy to treat Parkinson’s disease

The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%

UK pushes space-made medicines from orbit to patients with new support package

The initiative provides clearer regulatory guidance and a defined path from research in space to patient access on Earth

Frontage Laboratories expands China presence with Teddy Lab acquisition

GAIA and Daiichi Sankyo Europe join forces to launch groundbreaking digital therapeutic for heart health

Germany will be the first launch market

Lonza expands manufacturing pact with Genetix to meet rising demand for gene therapy ZYNTEGLO

Avio Smart teams up with Huwel Lifesciences to roll out next-gen molecular diagnostics in India

Huwel’s diagnostic solutions leverage open RT-PCR system

FDA nod to Bristol Myers Squibb’s Sotyktu as new oral therapy for psoriatic arthritis

The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials

EU unveils draft guidance to fast-track clinical trials during public health emergencies

The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations