Latest Biotech News

The FDA revisited years-old data issues around Tavneos (avacopan) and asked Amgen to consider withdrawing the drug; Amgen pushed back and said it is unwilling to pull the product from the market....

Two AI-native ventures signaled momentum: Latent Labs, founded by former DeepMind team members, emerged with a platform to design drug-like biologics for difficult targets; Phylo raised $13.5...

The Joint Action on Personalized Cancer Medicine (JA PCM) launched with €25.3 million from the EU to expand equitable access to personalized prevention, early detection and treatment across 29...

This week’s flurry of IPOs continued as Agomab Therapeutics and SpyGlass Pharma raised a combined $350 million in separate offerings, and Veradermics priced a $256 million IPO for its oral...

Two European and multiple US biotechs priced sizeable offerings this week, reviving investor interest in drug-company IPOs. Belgium-based Agomab and ocular-therapy developer SpyGlass together...

Generate:Biomedicines, the Flagship Pioneering-backed antibody and programmable-biology company, filed for an IPO as it advances phase 3 programs and AI-designed antibody candidates. The filing...

Telehealth provider Hims & Hers announced it will sell a compounded version of Novo Nordisk’s recently approved Wegovy pill, triggering a public clash with Novo and raising immediate legal and...

The White House announced plans to launch TrumpRx, a direct-to-consumer pricing portal built on GoodRx technology to display cash prices for selected medicines and steer patients to purchase...

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...