Latest Biotech News

Bayer reported that asundexian, its factor XIa inhibitor, reduced recurrent ischemic stroke by 26% in a large Phase 3 trial, data the company says arrived without accompanying safety concerns....

The FDA issued a safety communication expanding DPYD-related labeling to encompass both capecitabine (Xeloda) and intravenous 5‑fluorouracil (5‑FU), urging clinicians to assess dihydropyrimidine...

BARDA announced the first stage of a $100 million prize competition aimed at spurring development of broad‑spectrum small‑molecule antivirals targeting Togaviridae and Flaviviridae families. The...

Two financing moves signal continuing venture activity in biotech and bio‑AI: Santé Ventures closed a $330 million Fund V to back early‑stage biotech, medtech and digital health companies, while...

Congress included reauthorization of the Pediatric Priority Review Voucher (PPRV) program in a government funding bill, extending the incentive through 2029. The move restores a policy tool that...

China’s State Council updated the Drug Administration Law to enforce lifecycle accountability across drug development and commercialization, signaling stricter oversight and longer regulatory...

Hims & Hers began selling a compounded oral version of Novo Nordisk’s newly approved Wegovy pill, prompting immediate legal threats from Novo. The telehealth company framed the product as an...

The White House announced the launch of TrumpRx, a direct-to-consumer drug-pricing hub intended to display cash prices and direct patients to purchase options. The site, confirmed by White House...

Bayer disclosed Phase 3 data showing its factor XIa inhibitor asundexian cut recurrent ischemic strokes by 26% without new safety signals, a finding presented at the International Stroke...

Eikon Therapeutics priced an upsized Nasdaq IPO that raised $381 million to fund clinical development of oncology programs, marking the largest biotech IPO since 2024. The company plans to...

Generate:Biomedicines, the Flagship Pioneering-founded AI-enabled antibody company, filed for an IPO to fund late-stage development of engineered protein therapeutics including GB-0895 and...

Eli Lilly reported stronger-than-expected results and a bullish 2026 outlook, while Novo Nordisk warned of a 5–13% sales decline next year amid pricing concessions from U.S. deals and rising...

A large Chinese study published in BMJ found that HPV testing on menstrual blood collected via a sanitary-pad strip matched clinician-collected cervical samples for detection of high-risk HPV...

U.S. regulators revisited pivotal-trial adjudication issues and asked Amgen to withdraw Tavneos (avacopan), citing concerns tied to re-adjudicated endpoint data. Amgen publicly refused the...

More than two years after approval, Vertex’s CRISPR-based sickle-cell treatment Casgevy has treated only about 60 patients worldwide, with specialty centers reporting a key bottleneck:...

BC Platforms struck a deal to integrate OmicsBank’s datasets—covering over 12 million patients in India and 500,000 in the UAE—into its BC Unify platform, expanding access to genomic, imaging and...

Eikon Therapeutics priced an upsized Nasdaq offering that raised $381 million, marking the largest biotech IPO since 2024. The company said proceeds will prioritize clinical development of EIK1001...

Flagship Pioneering‑backed Generate:Biomedicines filed for an IPO, highlighting an AI-enabled discovery engine and several clinical programs including GB‑0895 (anti‑TSLP) now in phase 3. The S‑1...

Novo Nordisk told investors it expects 2026 sales and operating profit to decline—forecasting a 5–13% drop—after agreeing to U.S. price concessions for Wegovy. Executives said the company still...

Pfizer reported Phase 2 results for PF‑3944, the monthly GLP‑1 acquired via its $10B Metsera buyout, showing mean placebo‑adjusted weight loss up to ~12.3% at 28 weeks in some cohorts. The company...