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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...
FDA approval of adjuvant pembrolizumab–belzutifan for high-risk clear cell RCC
The FDA approved an adjuvant combination of pembrolizumab and belzutifan for adults with high-risk clear cell renal cell carcinoma after surgery. The decision follows translational work from...
Rare-disease regulatory fight over avacopan (Tavneos)
Amgen is pushing back against FDA concerns that could remove Tavneos (avacopan) from the market, according to reporting on the company’s request for an independent review. The dispute centers on...
Record-setting biotech IPOs and market access
Parabilis Medicines’ Nasdaq debut continued the biotech IPO rebound after the company raised $670 million, following other mega-listings that have restored public-market momentum. The reporting...
Non-invasive fecal immunochemical testing paired with microbiome signals for CRC risk
Researchers in Turin used residual fecal immunochemical tests (FIT) to probe how the gut microbiome maps onto colorectal cancer risk, leveraging large population-based case-control data across the...
Non-invasive prenatal sequencing claims accuracy parity
A prenatal diagnostics approach called non-invasive fetal sequencing (NIFS) was presented as matching the accuracy of invasive genetic screening methods while reducing safety risks and cost. The...
GLP-1 safety signals tied to fainting and dizziness
Northwestern Medicine researchers reported a safety concern linked to GLP-1 receptor agonists: increased incidence of fainting and dizziness events consistent with hypotensive effects. The work...
Clinical microbiology advance: safe deliberate colonization with non-toxigenic C. difficile
A Nature Communications study reported results from a human trial testing deliberate colonization with a non-toxigenic Clostridioides difficile strain. Led by Hensen, Harmanus, Verbeek-Menken and...
New genetic medicine platform funding for ultrasound-mediated delivery
SonoThera raised $125 million in an oversubscribed Series B to advance ultrasound-mediated genetic medicines. The financing was led by Vida Ventures and includes investors such as ARK Invest,...
Precision pathology commercialization through Leica and DiaDeep
Leica Biosystems expanded efforts to commercialize AI-driven oncology pathology tools via the Aperio AI Store by partnering with DiaDeep, a Lyon-based medical AI company. The reseller deal makes...
Rare disease regulation and FDA scrutiny
Amgen escalated its fight over FDA scrutiny of Tavneos (avacopan) by asking for an independent review, according to reporting on the company’s dispute. The request follows FDA concerns tied to...