Latest Biotech News

Europe moved to greenlight Sanofi’s MS therapy Cenrifki (tolebrutinib) after U.S. regulators previously rejected it. Sanofi received a positive CHMP opinion for Cenrifki for non-relapsing...

Grace Therapeutics’ lead aneurysmal subarachnoid hemorrhage program hit a regulatory roadblock as the FDA issued a complete response letter for GTx-104. The CRL cited manufacturing and...

Researchers reported a strategy to genetically program neutrophils in vivo for glioma treatment, targeting a longstanding limitation in cell-based engineering. The work describes direct genetic...

New cancer biology findings pinpoint KMT2C/D loss as a targetable weakness by linking the alteration to downstream dependencies in tumor growth. The study frames KMT2C/D as part of broader...

DeepDrugDiscovery unveiled an AI screening platform designed to discover blood–brain barrier–permeable autophagy enhancers for Alzheimer’s disease. The platform focuses on a core translational...

The FDA accelerated review for three psychedelic programs by issuing national priority commissioner’s vouchers under a Trump administration push to expand access to mental health...

Ferrosa Therapeutics raised seed funding to advance a bispecific antibody program aimed at treating anemia of inflammation across kidney disease, autoimmune disorders, and oncology. The company...

Inventiva expanded its executive leadership as the company prepares for a Phase III readout in metabolic dysfunction-associated steatohepatitis (MASH). Inventiva appointed Axel-Sven Malkomes as...

Avalyn Pharma outlined plans for an IPO targeting proceeds to accelerate clinical development of inhaled respiratory therapies. The company set an approximately $182 million IPO goal, aiming to...

One Biosciences, backed by Institut Curie, selected Albany, New York, for its first U.S. location to build a high-complexity lab and computational analytics operation. The company plans to use...

EMA’s CHMP has recommended approval of Sanofi’s tolebrutinib for a defined subset of non-relapsing secondary progressive multiple sclerosis, a reversal for the program after the FDA issued a...

The FDA has moved to speed review timelines for three psychedelic-focused programs using national priority commissioner vouchers tied to mental health indications. The agency’s fast-track approach...

Grace Therapeutics said the FDA issued a complete response letter for its GTx-104 NDA, delaying a potential update to care for aneurysmal subarachnoid hemorrhage. The agency’s concerns were...

UCB has agreed to acquire Neurona Therapeutics for up to $1.15 billion, positioning the epilepsy specialist’s lead asset NRTX-1001 as a core addition to UCB’s neurology growth strategy. The deal...

Inventiva has added three executives to its C-suite as it prepares for a Phase III readout in 4Q26 for lanifibranor in metabolic dysfunction-associated steatohepatitis. The leadership changes...

Researchers reported in Nature Metabolism that cell-specific DNA methylation programs help drive gene expression differences between pancreatic alpha and beta cells across the lifespan and in type...

Researchers reported advances in in vivo CAR-neutrophil engineering aimed at glioma treatment, tackling a longstanding hurdle in cell-based therapies: direct genetic programming of neutrophils....

Public markets tracked continued valuation adjustments and pipeline re-rating as investors assessed new data and deal timing. In the same coverage cycle, Lilly’s activity and broader pharma moves...

A quality improvement initiative in neonatal critical care was reported to optimize safe, rapid transport of critically ill newborns to specialty centers. In the analysis published in Pediatric...

A new smart finger-cuff algorithm showed high accuracy for detecting moderate-to-severe aortic stenosis among African American patients in the REACH trial. Results were presented at the SCAI 2026...