Latest Biotech News

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...

A group of physicians and Prader-Willi syndrome experts notified clinicians about potential safety concerns tied to Neurocrine Biosciences’ newly approved Vykat XR (sparсaple?) through the FDA’s...

July FDA approvals delivered first products for three biotechs, including Vera Therapeutics’ accelerated approval for Trutakna (atacicept) in primary immunoglobulin A nephropathy, with Celcuity...

The FDA rejected ITM Isotope Technologies Munich’s radiotherapeutic ITM-11 (177Lu-edotreotide) for gastroenteropancreatic neuroendocrine tumors, citing manufacturing problems at a third-party...

AbCellera reported positive Phase 2 top-line results for ABCL-635, an injectable neurokinin-3 receptor antagonist for menopausal vasomotor symptoms. In a randomized, double-blind,...

Sionna Therapeutics said its Phase 2 add-on approach for cystic fibrosis did not deliver benefit when combined with Vertex’s Trikafta. In the trial, SION-719 plus Trikafta failed to show a...

UK biotech investment surged in Q2 2026 to a five-year high, reaching £2.11 billion ($2.84 billion) in equity financing, including a record-breaking £2.05 billion in VCl, according to an interview...

Vaderis Therapeutics secured an oversubscribed $152 million Series B to advance engasertib (VAD-044) in hereditary hemorrhagic telangiectasia. The financing was co-led by Life Sciences at Goldman...

Infinimmune announced a $75 million Series A to advance two antibody programs into the clinic for atopic dermatitis. The round was co-led by Regeneron Ventures and Playground Global, with...

Ying Huang, formerly CEO of Legend Biotech, stepped into the CEO role at K2 Therapeutics as part of a C-suite overhaul. K2’s focus includes building a multimodal oncology pipeline and pursuing new...

Natera said it is preparing to expand beyond its U.S. MRD footprint after accruing multiple regulatory wins across geographies. The company highlighted FDA approval for Signatera in...