Eyestem moves closer to blindness breakthrough with phase 2 trial green light

The early-stage trial demonstrated an excellent safety profile alongside clinically meaningful improvements in visual acuity

Ionis and Otsuka score EU nod for DAWNZERA, offering new hope for rare HAE patients

The EU approval of DAWNZERA is an important milestone that reflects our ongoing commitment to bring this innovative medicine to people in need across the globe

FDA endorses Relmada’s registrational strategy for bladder cancer therapy

FDA nod to first-ever treatment for fatal pediatric Menkes disease

Jaguar Health wins $240,000 FDA grant to advance dog cancer diarrhea treatment

The company said it received notice on January 1 from the FDA’s Center for Veterinary Medicine that the funding will support its ongoing effectiveness study of Canalevia-CA1

FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA

The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement

FDA flags uncertainty over PFAS in cosmetics, calls for more research

Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety

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

FDA nod to first new motion sickness drug in 40 years

The approval is supported by data from three pivotal clinical trials

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