Latest Biotech News

Thermo Fisher Scientific has completed the sale of its microbiology business to European private equity firm Astorg, with the unit now operating as an independent company serving clinical,...

Vaderis Therapeutics closed an oversubscribed $152 million Series B to advance engasertib (VAD-044) for hereditary hemorrhagic telangiectasia (HHT) and initiated its global Phase III HEROIC study...

Natera partnered with Kupando Therapeutics to use Natera’s Latitude circulating tumor DNA (ctDNA) molecular residual disease assay in a Phase I skin cancer trial in Germany. The study will track...

The FDA has approved Takeda’s first-in-class oral orexin receptor 2 agonist Orzeyful (oveporexton) for adults with narcolepsy type 1. Takeda said the therapy is designed to address an underlying...

Vaderis was not the only company pushing toward late-stage execution this week—Definium’s psychedelic program also notched another Phase 3 win, while separate funding news highlighted continued...

Definium Therapeutics said its LSD-derived therapy eased generalized anxiety disorder symptoms in the first of two planned Phase 3 studies. The randomized trial enrolled 214 patients receiving a...

The FDA rejected ITM Isotope Technologies Munich’s radiotherapeutic ITM-11 (177Lu-edotreotide) due to manufacturing problems, issuing a complete refusal to approve. The decision delays a potential...

The FDA approved Moderna’s mRNA-1010 (mFLUSIVA), marking the first FDA-authorized flu vaccine designed as an mRNA product. Company and regulator materials tied the decision to positive Phase III...

N6 Tec expanded distribution for its IconPCR thermocyclers across Europe, the Middle East and Africa, adding new partners and extending existing ones. The company said it broadened Morpho...

Separate healthcare investments signaled continued scaling of research infrastructure and clinical access initiatives. In Houston, Bristol Myers Squibb selected the site for a $2.3 billion...

Neurocrine Biosciences’ newly approved Prader-Willi syndrome drug Vykat XR is facing serious scrutiny after a group of physicians and experts notified clinicians of patient deaths and severe...

Sionna Therapeutics’ cystic fibrosis program suffered a major blow after its Phase 2 add-on strategy failed to improve outcomes when layered on top of Vertex Pharmaceuticals’ Trikafta. In the...

Vaderis Therapeutics closed an oversubscribed $152 million Series B to advance engasertib (VAD-044) toward a Phase 3 program for hereditary hemorrhagic telangiectasia (HHT). The round was co-led...

The FDA has approved Takeda’s Orzeyful (oveporexton), the first therapy designed to address the underlying cause of narcolepsy type 1 in adults. Takeda’s orexin receptor 2 agonist marks a...

AbCellera reported positive Phase 2 topline results for ABCL635, an NK3R antagonist antibody intended as a long-acting, non-hormonal option for moderate-to-severe vasomotor symptoms due to...

Jazz Pharmaceuticals agreed to buy Actio Biosciences in a deal valued at up to $1.3 billion, adding a new ultra-rare epilepsy pipeline asset to Jazz’s portfolio. Under the agreement, Actio will...

The FDA rejected ITM Isotope Technologies Munich’s radiopharmaceutical agent ITM-11 due to manufacturing issues, delivering a complete stop for a potential challenger to Novartis’ Lutathera in...

Infinimmune secured a $75 million Series A to advance its antibody pipeline for atopic dermatitis, targeting IL-22 and IL-13 with two clinical candidates designed for longer-term control. The...

Analysis from Bourne Partners says lack of regulatory clarity is slowing AI adoption across the clinical trials ecosystem, including sponsors and contract research organizations. The report argues...

CMS and HRSA moved to adjust 340B drug pricing mechanics and reimbursement transparency through new rules and a revised rebate model pilot. CMS proposed changes to payment rates under the 340B...