Latest Biotech News

The FDA extended its review of Exelixis’ colorectal cancer drug candidate after the company submitted additional safety and efficacy data related to its potential treatment of metastatic...

Echo IQ disclosed that the U.S. FDA issued a not substantially equivalent determination for its initial 510(k) submission for Echosolv HF, delaying U.S. commercial clearance for the company’s...

Alzheon outlined plans for a major fundraising round despite a Phase 3 miss for its Alzheimer’s drug candidate. The company signaled it is pursuing up to $500 million to fund next steps as it...

Biotech IPOs in 2026 are showing broad gains through August, with 18 of 21 companies trading above their IPO prices as of Sept. 1 and 13 up more than 30%, according to BioCentury’s analysis of...

Archimed closed its MED IV healthcare investment fund at €1.5 billion, exceeding its original €1.2 billion target and attracting three-times oversubscription. The firm said it will deploy capital...

Encoded Therapeutics closed a $275 million Series F to advance its Dravet syndrome gene therapy into clinical trials. The bulk of the capital will fund studies of ETX101, targeting infants and...

Samsung Biologics signed a $262 million manufacturing agreement with a European pharmaceutical company, with commitments planned for production at its Songdo facility through 2033. Samsung said...

Might be a repeat in your feed: the newsletter already covers Encoded’s Dravet financing, but this cluster instead highlights another capital-intensive genetics effort in the same therapeutic...

A U.K. national commission published recommendations to update how AI-enabled healthcare products are regulated, arguing the Medicines and Healthcare products Regulatory Agency’s oversight powers...

Kura Oncology has spun out Caspian Therapeutics to pursue next-generation menin inhibition for diabetes and other cardiometabolic diseases, funding the program with a $50 million financing led by...

The FDA has taken two notable actions affecting drug access and development plans: it partially paused Biohaven’s epilepsy program on safety questions and expanded Bayer’s Hyrnuo lung cancer label...

Karyopharm has pushed off a debt payment while negotiating with creditors and exploring options for a potential deal, according to the latest company update. The move keeps attention on near-term...

Encoded Therapeutics has closed a $275 million Series F to move ETX101 into clinical trials for Dravet syndrome, funding additional studies and expanding its internal manufacturing strategy. The...

Teijin, Teijin Regenet, and Shinshu University Hospital have entered a joint research agreement aimed at advancing cell and gene therapy manufacturing technologies in Japan. The collaboration...

Luma Group closed a $410 million life sciences fund targeting therapeutics, medical devices, diagnostics, and digital health across the US, Europe, and Israel, with an emphasis on companies from...

Researchers reported that exosomes carrying anti-miR-221 cargo combined with gemcitabine can curb pancreatic cancer growth in preclinical models. The approach targets miR-221, a microRNA...

A new industry analysis highlighted that the biggest barriers for mRNA neoantigen cancer vaccines are less about clinical efficacy and more about scaling production. Personalized vaccines require...

ARPA-H launched the ADVOCATE program to fund health technology companies building AI agents intended for authorized clinical use, aiming to accelerate agentic tools for real-world care. The...

Full-Life Technologies’ [225Ac]Ac-FL-261 received regulatory clearances in the US and Australia to begin a first-in-human Phase I trial for c-MET-expressing nonsquamous NSCLC. The clearance...

The FDA signaled a willingness to adjust how psychedelic therapies are evaluated, with regulators saying they are open to “innovative approaches” including non-placebo comparators. The comments...