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FDA demands sham-controlled trial for life‑prolonging Huntington’s gene therapy
The U.S. Food and Drug Administration told uniQure it expects a prospective, randomized, double-blind, sham-surgery–controlled study to support approval of AMT‑130, a one-time AAV-based gene...
Earendil raises $787M... AI-driven biologics startup scales toward clinic
AI-native biotech Earendil Labs secured $787 million in private funding to accelerate a large pipeline of biologics across autoimmune and oncology programs and to expand R&D operations in the U.S....
Retatrutide hits phase III endpoints — triple‑agonist shows A1C and weight gains
Eli Lilly announced positive top-line results from Transcend‑T2D‑1: retatrutide—a triple agonist targeting GIP, GLP‑1 and glucagon receptors—met primary and key secondary endpoints in a Phase III...
Wegovy HD approved: FDA uses commissioner voucher to speed review
The FDA approved Novo Nordisk’s high‑dose Wegovy (7.2 mg) under a commissioner voucher program that expedited the review to roughly 54 days. The clearance expands dosing options for adults with...
Novartis pays $2B for next‑generation PI3Kα to shore up breast‑cancer franchise
Novartis agreed to acquire Pikavation Therapeutics—a Synnovation subsidiary—paying $2 billion upfront for a selective, pan‑mutant PI3Kα inhibitor (SNV‑4818) aimed at breast cancer, with up to $1...
Engineered esophagus integrates in growing pigs—functional graft restores feeding
A Nature Biotechnology study from Great Ormond Street Hospital and UCL reports an autologous engineered esophageal segment that restored oral feeding and peristalsis in growing minipigs without...
Tumor whole‑genome sequencing shows routine clinical impact in solid cancers
A real‑world series of 888 patients in a comprehensive cancer center—reported in Nature Medicine—shows paired tumor‑normal whole‑genome sequencing (WGS) succeeded in 89% of cases with a median...
FDA seeks public input on commissioner’s voucher pilot ahead of summer meeting
The FDA opened a request for feedback ahead of a public meeting to evaluate an expedited review voucher pilot that has already accelerated four drug approvals. The agency is soliciting stakeholder...
Earendil Labs hauls in $787M — AI biologics bankroll expands
Earendil Labs closed a $787 million financing to accelerate an AI‑driven biologics pipeline spanning autoimmune disease and oncology. The round included Dimension, Luminous Ventures and Sanofi and...
FDA clears high‑dose Wegovy under voucher — Novo wins fast review
The U.S. Food and Drug Administration granted approval for a higher‑dose Wegovy (7.2 mg) under the commissioner's voucher program, accelerating review to roughly 54 days after filing. Novo Nordisk...
Lilly’s triple‑agonist retatrutide meets Phase III goals — diabetes and weight outcomes
Eli Lilly reported positive top‑line Phase III results for retatrutide, a GIP/GLP‑1/glucagon triple‑agonist, showing clinically meaningful reductions in A1C and large weight loss in adults with...
Novartis pays $2B up front for Synnovation PI3Kα programs — franchise defense
Novartis agreed to acquire Pikavation Therapeutics, a Synnovation subsidiary, for $2 billion up front to secure next‑generation pan‑mutant PI3Kα inhibitors including SNV‑4818. The deal could reach...
Muscle‑building hopes fade — Roche and Genentech halt candidates
Roche announced it will stop development of emugrobart after key studies failed to show consistent improvements in muscle growth and motor function. Separately, Genentech ended development of a...
FDA presses for sham‑surgery control in uniQure’s Huntington gene trial — regulator unmoved by external controls
The FDA has told uniQure that external‑control data from Phase I/II studies are insufficient and recommended a prospective, randomized, double‑blind, sham‑surgery‑controlled trial of AMT‑130, an...
Tumor whole‑genome sequencing shows real‑world clinical utility — Nature Medicine series
A Nature Medicine real‑world analysis of 888 patients demonstrated that routine paired tumor‑normal whole‑genome sequencing (WGS) succeeded in 89% of cases with a median 6‑working‑day turnaround...
Abbott to close Exact Sciences buy — $23B deal seals diagnostics push
Abbott announced the completion of its $23 billion acquisition of Exact Sciences after securing regulatory clearances and shareholder approval. The move brings Cologuard, Oncotype DX and...
Nautilus Voyager lands Baylor access — single‑molecule proteomics readied for research use
Nautilus Biotechnology added Baylor College of Medicine as the first customer in its Voyager early access program, enabling Baylor investigators to test the platform’s single‑molecule proteomics...
In vivo CAR‑T edges closer — researchers reprogram T cells inside living hosts
Researchers reported methods to generate functional CAR‑T cells directly in vivo through targeted genetic engineering, demonstrating on‑target reprogramming of endogenous T cells without ex vivo...
Earendil Labs raises $787M — AI platform scales drug pipeline
Earendil Labs announced a $787 million private financing to expand an AI-driven drug discovery platform that the company says has produced more than 40 programs. The funding positions Earendil to...
Verily raises $300M: Alphabet loses majority control
Verily secured $300 million in outside capital that ends Alphabet’s controlling stake in the healthcare innovation company, the firm announced. The financing—led by Series X Capital with other...