Latest Biotech News

Eli Lilly said its triple-agonist retatrutide cleared the primary endpoints in two Phase 3 obesity trials, but the company also acknowledged the cardiovascular risk reduction signal was less clear...

GSK won FDA approval for Jideytro (zidesamtinib), moving rapidly from deal close to commercialization after acquiring Nuvalent for $10.6 billion last week. The approval covers adults with locally...

Arrowhead reported positive Phase 3 results for Redemplo (plozasiran) in severe hypertriglyceridemia, setting up a supplemental NDA filing with the FDA before year-end. The company said the drug...

Samsung Biologics proposed an all-cash tender offer of about $1.8 billion to acquire Switzerland-based PolyPeptide Group, a CDMO specializing in peptide-based APIs. The deal is Samsung’s...

The U.S. Senate approved the Affordable Prescriptions for Patients Act (S. 1041) in a unanimous vote July 21, moving the bill to the House after it sat on the Senate floor for more than a year....

The U.S. FDA launched its PreCheck Pilot Program, selecting seven companies—including Eli Lilly, Cellares, Fujifilm, Regeneron, Kyowa Kirin, and Kriya Therapeutics—to receive early,...

Cell-therapy manufacturers are adapting quality systems to address particulate inspection challenges as clearer regulatory guidance remains limited. CMC consultants say particulates in...

Seegene received FDA emergency use authorization for Allplex HSV-1&2/VZV/MPXV, a multiplex real-time PCR assay intended to detect and differentiate herpes simplex virus, varicella-zoster virus,...

Researchers led by UC San Diego reported that personalized antisense oligonucleotides reduced seizure frequency in two boys with SCN2A-related developmental and epileptic encephalopathies, as...

Transcripta Bio raised $24 million to advance IND-enabling studies and prepare clinical work for a neurological disease small-molecule portfolio spanning autism spectrum disorder and...

GSK said the U.S. FDA has approved Jideytro (zidesamtinib), delivering its first regulatory win from the company’s recently closed $10.6 billion Nuvalent acquisition. The drug is indicated for...

Arrowhead Pharmaceuticals reported positive top-line Phase III results for plozasiran (Redemplo) in severe hypertriglyceridemia (sHTG), a readout that follows its existing rare-disease approval in...

Samsung Biologics announced an all-cash tender offer to acquire PolyPeptide Group AG for about CHF 1.46 billion (roughly $1.8 billion), proposing what the company described as its largest-ever...

The NIH launched Bio Genesis Mission, an AI-backed initiative intended to accelerate biomedical research across multiple development tracks. The effort sits within Genesis Mission, a broader...

The U.S. Senate passed the Affordable Prescriptions for Patients Act (S. 1041) in a unanimous vote, moving legislation aimed at reducing biologics patent thickets toward the House. The bill limits...

The FDA launched its PreCheck Pilot program to engage earlier in the facility readiness process for new domestic pharmaceutical manufacturing, aiming to strengthen U.S. drug supply chains. The...

Assured Health secured $19 million to develop AI agents that help health systems and group practices move providers into in-network status faster. The startup said its agentic AI handles tasks...

A UC San Diego-led team reported personalized antisense oligonucleotide (ASO) approaches for two boys with rare SCN2A-related developmental and epileptic encephalopathies, with results published...

Cell-therapy manufacturers are adopting workarounds for particulate testing as regulatory guidance remains unclear for products that contain cells, according to a report focused on CMC inspection...

New reporting on biotech and med-tech capital markets highlights improving fundraising conditions alongside a wave of larger transactions. One dataset review found early 2026 showed strong series...