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Programmable in vivo CAR‑T: Dual‑vector system inserts large DNA payload
Researchers at UCSF reported a method to generate CAR T cells directly inside living hosts by delivering a large DNA sequence and achieving site-specific integration with a dual‑vector approach....
Retatrutide: triple‑agonist slashes A1C and sheds 36.6 lbs in Phase III
Eli Lilly disclosed top‑line results from a phase III trial showing retatrutide, a triple agonist targeting GLP‑1, GIP and glucagon receptors, produced substantial glycemic control and weight loss...
FDA greenlights high‑dose Wegovy — approval fast‑tracked by commissioner’s voucher
The FDA approved a 7.2 mg high‑dose formulation of Novo Nordisk’s semaglutide injection (Wegovy HD) under a commissioner’s voucher that expedited review to roughly 54 days. Novo won clearance for...
J&J's Icotyde: FDA clears oral IL‑23 pill for plaque psoriasis
Johnson & Johnson and Protagonist won FDA approval for Icotyde (icotrokinra), the first oral IL‑23 receptor antagonist cleared for moderate‑to‑severe plaque psoriasis in adults and adolescents....
Nautilus Voyager lands Baylor: single‑molecule proteomics enters cancer research
Nautilus Biotechnology opened early access to its Voyager single‑molecule proteomics platform by naming Baylor College of Medicine its first customer in an early access program. Baylor will use...
Collegium buys AZSTARYS from Corium for $650m — ADHD play
Collegium Pharmaceutical agreed to acquire Corium Therapeutics’ FDA‑approved ADHD product AZSTARYS for $650 million upfront plus up to $135 million in milestones to expand its neuropsychiatric...
Verily raises $300m; Alphabet cedes majority control
Verily closed a $300 million funding round that reduced Alphabet’s ownership and ended its majority control of the healthcare‑focused unit. The Series X‑led capital infusion brings new outside...
TerraPower to build $450m actinium‑225 plant — nuclear supply for radiotherapies
TerraPower Isotopes announced plans to build an actinium‑225 production facility in Philadelphia with a projected $450 million cost and production start targeted for 2029. The company said the...
Gilead hands HBV candidate back to Assembly — ABI‑4334 rights revert
Gilead informed Assembly Biosciences that it would not exercise its option for the next‑generation hepatitis B capsid assembly modulator ABI‑4334, returning full rights to Assembly. The move...
Arvinas PROTAC penetrates brain: ARV‑102 halves LRRK2 in CSF
Arvinas presented Phase 1 data showing oral PROTAC ARV‑102 achieved approximately ≥50% reduction of LRRK2 protein in cerebrospinal fluid after 14 days and maintained reduction through 28 days in...
Lilly’s triple‑agonist posts phase III win — A1C down, dramatic weight loss
Eli Lilly reported positive top-line results from Transcend‑T2D‑1, a phase III trial of retatrutide, a first‑in‑class GIP/GLP‑1/glucagon triple agonist. The study showed clinically meaningful A1C...
FDA clears high‑dose Wegovy — Novo uses commissioner voucher for rapid review
The FDA approved Wegovy HD, a 7.2 mg once‑weekly formulation from Novo Nordisk, after an accelerated review under the commissioner's voucher program that cut the decision timeline to roughly 54...
J&J lands oral IL‑23 approval — Icotyde positioned to take on injectables
Johnson & Johnson and Protagonist won FDA approval for Icotyde (icotrokinra), an oral IL‑23 receptor antagonist for moderate‑to‑severe plaque psoriasis in adults and adolescents 12 and older. The...
CAR‑T made inside the body: targeted gene integration clears tumors in mice
Two independent reports describe major advances in generating CAR‑T cells directly in vivo. A UCSF‑led team demonstrated programmable, site‑specific integration of large DNA payloads into...
PROTAC clears CNS hurdle — Arvinas shows LRRK2 degradation in cerebrospinal fluid
Arvinas reported Phase 1 data for ARV‑102, a PROTAC degrader targeting LRRK2, demonstrating roughly 50% or greater LRRK2 reduction in cerebrospinal fluid at multiple dose levels by day 14 and...
FDA fast‑tracks oncolytic pelareorep for KRAS‑mutant CRC — response signals cited
The FDA granted fast‑track designation to pelareorep (Reolysin) in combination with bevacizumab and FOLFIRI for second‑line treatment of KRAS‑mutant, microsatellite‑stable metastatic colorectal...
Trillion Gene Atlas unveiled — massive evolutionary dataset to fuel AI drug design
Basecamp Research launched the Trillion Gene Atlas in partnership with Anthropic, Ultima Genomics and PacBio to expand evolutionary genetic diversity for AI‑driven therapeutic discovery. The...
Regulators shift away from animal studies — FDA drafts guidance, NIH marks progress
The FDA issued draft guidance outlining paths for validating New Approach Methodologies (NAMs) that can replace certain animal pharmacology and toxicology studies, signaling regulatory openness to...
Congress revives SBIR/STTR — seed funding rebooted for five years
Congress passed a five‑year reauthorization of the SBIR and STTR programs, restoring a critical federal seed‑funding mechanism for small biotech companies. The move ends a funding lapse and...
AstraZeneca builds China cell‑therapy hub — end‑to‑end manufacturing and R&D in Shanghai
AstraZeneca announced plans to create a Shanghai cell therapy research, development and manufacturing hub with capabilities spanning early R&D, clinical manufacturing and regulatory support for...