Latest Biotech News

Avalyn Pharma set out to raise capital for advanced development of inhaled respiratory therapies, signaling renewed public-market appetite for respiratory biotech. The company is targeting an IPO...

UCB is buying epilepsy-focused Neurona Therapeutics for up to $1.15 billion, underscoring how aggressively big pharma is bidding for late preclinical-to-clinical neurologic assets. The transaction...

Grace Therapeutics received an FDA complete response letter for its GTx-104 NDA, pausing plans to update the standard of care in aneurysmal subarachnoid hemorrhage. The agency cited manufacturing...

A data-driven approach to clinical trials is gaining attention as investigators look to reduce reliance on traditional placebo groups. Synthetic control arms use external datasets—such as...

New AI- and liquid-biopsy-adjacent tools are being positioned to improve cancer risk stratification and diagnostic throughput. City of Hope and UC Berkeley researchers reported a microfluidic...

Researchers advanced next-generation immune cell engineering for solid tumors by reporting in vivo CAR-neutrophils designed for glioma treatment. The work addresses a long-standing technical...

A set of cellular biology and molecular-engineering breakthroughs points to faster ways to see—and measure—complex biological systems. EPFL researchers developed CenSpark, a fluorescent probe that...

Kurma Partners closed its fourth and largest venture fund, signaling continued institutional backing for therapeutic pipeline builders. The €215 million fund is raised to pursue disruptive...

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...