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Regulatory dispute – Amgen’s Tavneos bid to stay on market
Amgen has asked the FDA for continued approval review of Tavneos (avacopan), arguing the drug’s risk-benefit profile supports keeping it on the market amid concerns raised by the agency. The FDA’s...
Clinical data – first pivotal-stage GPC3 CAR-T for liver cancer
Oricell’s glypican-3 (GPC3)-targeted autologous CAR T, Ori-C101, has moved into a confirmatory registration Phase 2 trial for GPC3-positive advanced hepatocellular carcinoma. The company positions...
Clinical trial – single-dose mRNA vaccine protects against Andes hantavirus in animals
Researchers at UTMB reported that an Andes hantavirus mRNA vaccine provides full protection after a single dose in a golden Syrian hamster model. The work, published in The Lancet, builds on...
Platform + funding – ultrasound-mediated genetic medicines raise Series B
SonoThera raised $125 million in an oversubscribed Series B round to advance ultrasound-mediated delivery of genetic medicines for Duchenne muscular dystrophy (DMD) and autosomal dominant...
Precision medicine tools – long-read sequencing streamlines rare disease diagnostics
Implementation results presented at the European Society of Human Genetics meeting in Gothenburg show that first-tier long-read genome sequencing can reduce follow-up testing and shorten time to...
AI + diagnostics workflow – DNA analysis via long-read sequencing expands
Radboud University Medical Center and Maastricht UMC+ published clinical long-read genome sequencing work using a comprehensive rare-disease test design, aiming to improve accuracy and efficiency...
Oncology – engineered oncolytic VSV targets metastatic ovarian cancer
Researchers reported ErbB-OSV, an engineered vesicular stomatitis virus variant designed to selectively target metastatic ovarian cancer while sparing normal tissue. The study describes a...
Regulatory action / drug safety – GLP-1s linked to hypotensive events
Northwestern Medicine researchers reported a safety signal tying GLP-1 receptor agonists to increased incidence of fainting and dizziness, consistent with more hypotensive events. The finding adds...
Biopharma dealmaking – China drives biggest biopharma deal month since 2023
Biopharma deal value surged in the first five months of 2026, reaching $135.36 billion—above every prior year through the same window—and May delivered the year’s biggest month at $41.78 billion....
Regulatory approval in oncology
The FDA cleared an adjuvant regimen combining pembrolizumab with belzutifan for adults with high-risk clear cell renal cell carcinoma following surgery to remove all or part of the kidney. The...
FDA enforcement and drug approval challenges
Amgen is pushing back against the FDA as the agency weighs withdrawing Tavneos (avacopan), a rare vasculitis drug. According to the report, FDA concerns were raised in connection with securities...
Drug development—major clinical readouts
Takeda’s zasocitinib (TAK-279) beat Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a top-line phase III Latitude Atlas readout for moderate to severe plaque psoriasis. The result moves...
Biotech IPOs—market access and funding
Parabilis Medicines set a large biotech listing milestone, completing a $770.5 million IPO via the Nasdaq after underwriters exercised their overallotment option. The listing follows a streak of...
Deals and financing—capital markets activity
SonoThera raised $125 million in an oversubscribed Series B to advance ultrasound-mediated genetic medicines into clinical development. The round was led by Vida Ventures and included...
Clinical pipeline competition in rare disease immunotherapy
Oricell moved its GPC3-targeted immune cell strategy into confirmatory development for liver cancer. The company’s autologous CAR T therapy, Ori-C101, is entering a registration-focused phase II...
Precision oncology—diagnostics and MRD testing
Roche subsidiary Foundation Medicine rebranded Saga Diagnostics’ minimal residual disease test as FoundationOne MRD after acquiring Saga for $595 million earlier in 2026. The updated branding...
Immunology and infectious disease mechanism—viral inflammation signaling
A new study identified GPR84 as a driver of lung inflammation through PANoptosome activation in the context of influenza A virus infection. Researchers mapped a mechanistic chain linking the...
Generational diagnostics—genome sequencing implementation
A Dutch implementation study presented at the European Society of Human Genetics meeting reported that long-read genome sequencing as a first-tier test improved interpretation and reduced...
Regulatory and market risk—clinical-stage biotech capital activity
Summit Therapeutics pulled plans for a $500 million secondary share offering day after announcing it, citing market conditions. The company’s move followed a period of investor scrutiny around...
First-in-human partial cellular reprogramming gene therapy
Life Biosciences said it has treated the first participant in a gene therapy trial designed to partially reprogram aged cells by turning on three genes. The study targets glaucoma, aiming to...