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FDA clears Tenpoint’s dual‑agent presbyopia drop — startup secures $235M push
Tenpoint Therapeutics won FDA approval for Yuvezzi, a first‑in‑class combination eye drop (carbachol + brimonidine) for presbyopia, and closed up to $235 million in financing to support...
DeepMind releases AlphaGenome — AI predicts noncoding DNA function at scale
DeepMind published AlphaGenome, a long‑sequence DNA model that predicts regulatory activity and variant effects across up to one million base pairs, tackling the functional interpretation of...
Fractyl’s Revita shows large cut in post‑GLP‑1 weight regain — six‑month trial readout
Fractyl Health reported six‑month REMAIN‑1 results showing that its endoscopic procedure Revita reduced weight regain after GLP‑1 discontinuation by ~70% versus sham in patients who stopped...
Cellares raises $257M to scale cell‑therapy manufacturing ahead of IPO
Cellares closed a $257 million Series D to accelerate commercial launches of its cell therapy manufacturing automation and to support an anticipated 2027 IPO bid. The company’s integrated robotics...
Eikon targets $273–274M IPO to fund oncology imaging and discovery platform
Eikon Therapeutics set terms for an IPO to raise roughly $273–274 million, citing proceeds to advance its high‑throughput single‑molecule imaging platform and oncology pipeline. The company’s...
Thermo Fisher projects 4–6% revenue growth in 2026 — life‑sciences demand steadies
Thermo Fisher issued guidance for 2026 revenue growth of 4–6% and reported Q4 2025 results that beat estimates, driven by life‑sciences solutions and bioprocess strength. The company posted...
FDA halts Regenxbio studies — tumor found in trial participant
The U.S. Food and Drug Administration placed clinical holds on Regenxbio’s gene therapy programs after investigators identified a brain tumor in a treated participant. The hold affects trials for...
FDA designates NanoMosaic as AMT: gene therapy QC platform gains fast-track access
The U.S. FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Tessie platform for assessing gene therapy quality, enabling prioritized regulatory interactions for...
CMS names 15 drugs for round three negotiations — Part B biologics included
The Centers for Medicare & Medicaid Services released the slate of 15 medicines selected for the third round of Inflation Reduction Act price negotiations, marking the first time Part B...
Repertoire and Lilly expand autoimmune push — multibillion platform validation
Repertoire Immune Medicines signed a major collaboration with Eli Lilly to develop tolerizing therapies for autoimmune diseases, securing up-front and milestone payments that validate the...
Lilly backs recombinase editing — Seamless deal targets genetic hearing loss
Eli Lilly licensed Seamless Therapeutics’ recombinase gene editing platform in a collaboration worth up to roughly $1.12 billion to develop precision genetic medicines for hearing loss. The pact...
Tenpoint wins FDA approval for dual‑agent presbyopia drop — $235M financing closes
Tenpoint Therapeutics secured U.S. FDA approval for Yuvezzi, a dual‑agent eye drop combining carbachol and brimonidine for adult presbyopia, and concurrently closed up to $235 million in...
En Carta’s point‑of‑care Lyme test gets FDA breakthrough designation
En Carta Diagnostics received FDA Breakthrough Device Designation for EC Pocket Lyme, a rapid molecular point‑of‑care assay that detects Borrelia DNA from skin interstitial fluid using a...
DeepMind’s AlphaGenome debuts — community presses for validation
DeepMind published AlphaGenome in Nature, an AI model that predicts regulatory activity from long stretches of noncoding DNA up to one million base pairs and scores variant effects across...
Cellares raises $257M to scale cell therapy manufacturing ahead of IPO
Cellares closed a $257 million Series D to accelerate commercial roll‑out of its automated cell therapy manufacturing services and to prep for a planned 2027 IPO. The funding will expand global...
Summit’s PD‑1xVEGF bispecific accepted — FDA sets November decision date
The FDA accepted Summit Therapeutics’ BLA/MAA for ivonescimab, a PD‑1/VEGF bispecific antibody for non‑small cell lung cancer, and set a PDUFA decision date in November. Summit reported the filing...
FDA pauses Regenxbio gene trials: tumor found in child
The U.S. Food and Drug Administration placed clinical holds on Regenxbio’s gene‑therapy programs after a pediatric trial participant was diagnosed with a brain tumor. Regenxbio confirmed the holds...
Lilly inks up-to-$1.12B recombinase pact with Seamless
Eli Lilly struck an exclusive research-and-license agreement with Seamless Therapeutics worth up to $1.12 billion to apply Seamless’s programmable recombinase platform to genetic hearing‑loss...
Repertoire adds Lilly to partner roster — blockbuster autoimmune pact
Repertoire Immune Medicines expanded its pharma partnerships by signing Eli Lilly to a collaboration focused on tolerizing vaccines for autoimmune diseases, in a deal that could be worth up to...
Moderna and Merck report 49% drop in melanoma recurrence with mRNA combo
Interim five‑year data from a randomized Phase II trial show that combining Moderna’s personalized neoantigen mRNA candidate (mRNA‑4157/intismeran autogene) with pembrolizumab reduced melanoma...