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Latest Biotech News

FDA approval reshapes cardiovascular risk and epilepsy portfolios

August 28, 2026

Eli Lilly’s Mounjaro (tirzepatide) won FDA approval to reduce cardiovascular risk, adding a new label that could extend the blockbuster’s reach in cardiometabolic care. In parallel, Teva agreed to...

AstraZeneca heart gene-silencer setback at ESC

August 28, 2026

A surprise trial failure involving AstraZeneca and Ionis’ Wainua (eplontersen) has put pressure on RNA-targeting “silencer” therapies for TTR cardiomyopathy. Data discussed in connection with the...

Oncology: breakthrough FDA approval in pancreatic cancer and label expansion via diagnostics

August 28, 2026

Revolution Medicines secured a landmark FDA approval for daraxonrasib (Rasonque), a once-daily oral pan-RAS inhibitor for pancreatic ductal adenocarcinoma. Analysts characterized the regulatory...

Dealmaking: Genentech bets on DualityBio’s ADC payload platform

August 28, 2026

Genentech, part of Roche, agreed to pay DualityBio $45 million upfront to develop antibody-drug conjugates built around the company’s DUPAC payload platform, with milestone potential exceeding $1...

Early-stage portfolio: gene editing push at ESC and durable expansion plans

August 28, 2026

At ESC26, CRISPR Therapeutics said it will pursue the highest dose of its lipid-lowering gene editing therapy after presenting mixed durability results from early-stage data around a year after...

Biomarkers and real-world diagnostics: MRD coverage and workflows

August 28, 2026

NeoGenomics said its RaDar ST MRD assay received expanded coverage from CMS’s MolDX program to add immunotherapy response monitoring for late-stage solid tumors. The tumor-informed test uses...

Manufacturing and precision services consolidation

August 28, 2026

McKesson agreed to acquire Precision Medicine Group in a deal valued at about $2.25 billion, strengthening its oncology and clinical research services footprint. Precision Medicine Group...

Hospital and ecosystem: new deals to operationalize pharmacogenomics and infection control

August 28, 2026

Children’s Hospital Colorado signed a multi-phase agreement with GenXys Health Care Systems to integrate pharmacogenomic data into clinical workflows. The first phase focuses on processing genomic...

Immunotherapy risk signal: Fatal tumor lysis syndrome after starter dose

August 28, 2026

A case report in Respirology Case Reports described an initial 1-milligram dose of tarlatamab followed by fatal tumor lysis syndrome in a woman with relapsed small-cell lung cancer. The...

Pancreatic cancer breakthrough approval

August 28, 2026

The FDA has approved Revolution Medicines’ daraxonrasib (Rasonque) for advanced pancreatic ductal adenocarcinoma, marking the first approval of a drug specifically targeting a genetic driver in...

Antibody-drug conjugate licensing stakes rise

August 28, 2026

Genentech has expanded its ADC ambitions with a major licensing deal centered on DualityBio’s topoisomerase inhibitor payload platform. DualityBio said it will receive $45 million upfront and...

Regulatory: Roivant dermatomyositis drug clears FDA

August 28, 2026

The FDA approved Roivant’s brepocitinib, branded as Lisraya, for dermatomyositis—an oral therapy Roivant’s unit Priovant licensed from Pfizer. The approval provides a new steroid-sparing option...

AstraZeneca–Ionis heart drug fails after surprise setback

August 28, 2026

A high-profile heart drug program involving AstraZeneca and Ionis suffered a surprise failure, according to results discussed around the European Society of Cardiology meeting. The setback affects...

Cell therapy manufacturing dispute erupts at Cellares

August 28, 2026

Cellares said it is facing a major financial and operational blow after Bristol Myers Squibb terminated their manufacturing collaboration tied to Breyanzi (lisocabtagene maraleucel). The...

Epilepsy deals: Biohaven’s Kv7 asset gets commercial partner

August 28, 2026

SK Biopharmaceuticals agreed to acquire Biohaven’s opakalim (BHV-7000) epilepsy drug through a deal structured with $400 million at closing and up to $795 million total depending on milestones and...

Diverse regulatory and diagnostic progress in companion testing

August 28, 2026

Roche received FDA clearance expanding the use of its HER2 diagnostic tests tied to Jazz Pharmaceuticals’ Ziihera, extending patient identification beyond earlier approved stomach-cancer...

Biomanufacturing services deal: McKesson to acquire Precision Medicine Group

August 28, 2026

McKesson signed a definitive agreement to acquire Precision Medicine Group for about $2.25 billion in an all-cash transaction, aiming to expand clinical research and biopharma commercialization...

FDA / rare disease: Priovant’s Lisraya approval plus Roivant’s pipeline relevance

August 28, 2026

The FDA approval of Roivant’s brepocitinib for dermatomyositis reinforces how the agency’s decisions in rare autoimmune disease are continuing to shape commercial planning for “spoke” programs...

Clinical trial setback: Severe malnutrition therapies miss endpoints

August 28, 2026

An international Phase 3 trial testing pancreatic digestive enzymes and ursodeoxycholic acid in severely malnourished acutely ill children stopped early after interim analyses indicated neither...

Cardiovascular drug development: Cytokinetics’ nHCM pivotal data and regulatory pathway

August 28, 2026

Cytokinetics disclosed full pivotal trial results for aficamten in non-obstructive hypertrophic cardiomyopathy (nHCM), showing improvements in how patients felt and in exercise capacity. The...