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FDA proposes down‑classifying some companion diagnostics – 510(k) route opened
The FDA proposed reclassifying certain nucleic acid‑based companion diagnostics from Class III to Class II, which would allow affected devices to seek clearance via the 510(k) pathway rather than...
Gene-edited cell transplant restores insulin—no immunosuppression
Scientists reported the first successful transplantation of gene-edited, insulin-producing cells into a patient with type 1 diabetes, restoring endogenous insulin production without chronic...
Lilly’s triple agonist raises the bar — blockbuster weight loss readouts
Eli Lilly’s triple agonist retatrutide produced industry-leading weight-loss results in late-stage testing, with Phase 3 readouts showing roughly mid-to-high‑20s percent mean body-weight reduction...
AC Immune’s Parkinson vaccine posts biomarker gains…regulatory talks next
AC Immune reported interim data from its Phase II Vacsyn program showing coherent biomarker changes — reductions in aggregated α‑synuclein measures and supportive NfL and GFAP signals — that the...
FDA weighs boxed warning for Covid shots — experts sound alarm
Two news outlets reported that FDA officials are considering adding a boxed (black‑box) warning to COVID‑19 vaccines, citing internal deliberations at the agency and a leaked staff memo. Sources...
EMA’s December session backs multiple new drugs — CHMP recommendations roll out
The European Medicines Agency’s CHMP issued multiple favorable recommendations this month, endorsing new medicines from companies such as Hansoh and Cytokinetics and recommending recent filings...
China raises big biotech rounds — venture into surfaceome and diagnostics heats up
Chinese biotech financing accelerated this week as D3 Bio and Sanegene each announced >$100M rounds, and European surfaceome startup Disco closed a €36M seed to advance target discovery. Investors...
Diagnostics consolidation — Natera buys Foresight; Guardant links to trial‑matching AI
Natera announced an acquisition of Foresight Diagnostics to incorporate phased‑variant enrichment technology into Signatera and to expand into hematologic MRD testing, aiming to boost ctDNA...
FDA clears Medtronic embolic device — and OKs first at‑home brain‑stimulation headset
Regulators cleared two devices with broad clinical implications: the FDA approved Medtronic’s Onyx liquid embolic system for middle meningeal artery embolization as an adjunct to surgery for...
Umoja delays first in‑vivo CAR‑T readout — trial timeline slips
Umoja Biopharma announced a delay in its first clinical readout from its China-based in‑vivo CAR‑T study, citing operational and timing adjustments. The company, a leading developer of direct...
Arcus halts TIGIT push after Phase 3 failure — R&D refocus begins
Arcus Biosciences and partner Gilead announced a Phase 3 failure for anti‑TIGIT antibody domvanalimab in upper gastrointestinal cancers and said they will stop related phase III programs; an...
FDA intends black-box warning for Covid-19 vaccines — two sources
The FDA is reportedly preparing to add a boxed (black box) warning to one or more Covid-19 vaccines, according to two people familiar with the agency’s plans. The move has been tied in reports to...
Lilly’s triple agonist posts record weight loss — discontinuations raise flags
Eli Lilly’s experimental triple-agonist retatrutide produced unprecedented weight-loss results in a Phase 3 readout, with the high-dose arm delivering near‑30% mean body-weight reductions at...
AC Immune vaccine advances biomarkers in Parkinson’s — regulator talks planned
AC Immune reported interim biomarker data from its phase II Vacsyn program showing changes consistent with target engagement in early Parkinson’s disease. The company said cerebrospinal fluid...
Arcus stops TIGIT program after Phase 3 futility — partner trials scrapped
An independent data monitoring committee concluded a Phase 3 study of Arcus and Gilead’s anti‑TIGIT antibody domvanalimab would not meet its endpoints, prompting the partners to halt the upper‑GI...
Gene‑edited cell transplant restores insulin production in Type 1 patient — off immunosuppression
Researchers have successfully implanted gene‑edited, insulin‑producing cells into a man with type 1 diabetes and demonstrated endogenous insulin production without the need for chronic...
FDA clears new oral options for gonorrhea — treatment landscape widens
Regulators added two oral antibiotics to the gonorrhea treatment toolbox: Innoviva’s zoliflodacin (Nuzolvence) and GSK’s gepotidacin (Blujepa) secured approvals/label expansions as supplemental...
Natera buys Foresight, expands MRD and hematology push
Natera agreed to acquire Foresight Diagnostics for about $275 million to gain phased‑variant enrichment and detection sequencing technology aimed at improving minimal residual disease (MRD)...
Illumina backs MyOme trial — WGS plus AI to test population‑scale risk prediction
Illumina made a strategic investment in MyOme and will support a prospective clinical trial that pairs whole‑genome sequencing with MyOme’s AI risk models. MyOme said the Proactive Health trial...
Parse, Tahoe to sequence 300M cells — building an AI‑trained perturbation atlas
Parse Biosciences and Tahoe Therapeutics announced a collaboration to generate a 300 million‑cell single‑cell perturbation atlas to train artificial‑intelligence models. Parse will produce the...