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FDA approves first-in-class-like oral therapy for FGFR2-driven bile duct cancer
The FDA approved Elevar Therapeutics’ lirafugratinib (Lyrfigtu) as a second-line treatment for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma...
RNAi IPO surge: ADARx prices upsized offering with AbbVie backstop
ADARx Pharmaceuticals priced its $446.3 million Nasdaq IPO, continuing a wave of biotech public market momentum led by RNA-targeted companies. The RNA interference specialist sold more than 26...
Eli Lilly deepens China innovation push with new InnoCare R&D pact
Eli Lilly expanded its China drug-sourcing strategy by signing a discovery-stage collaboration with Beijing-based InnoCare Pharma. The partnership is structured around up to five undisclosed...
Roche and Genentech launch a $1.5B bispecific deal with Earendil Labs
Roche’s Genentech signed a wide-ranging bispecific antibody discovery and development collaboration with Earendil Labs, paying $55 million upfront. The agreement covers multiple bispecific...
Big Pharma shifts exit dynamics: CGT spending rises as acquisitions replace IPOs
A new dispatch argues that large biopharma is increasingly using cell and gene therapy deals as an exit route, replacing the role of biotech IPOs. The piece points to Eli Lilly’s CGT spending...
Enveda’s Series E underscores AI-led plant chemistry as clinical capital target
Enveda Biosciences raised a $311 million Series E to advance its AI-driven pipeline, positioning the company as one of the best-capitalized “AI-native” drug discovery startups in the market. The...
FDA advisory panel advances Grail Galleri; safety and effectiveness debated
An FDA advisory panel voted to endorse Grail’s Galleri multicancer blood test, saying the benefits outweigh the risks while acknowledging ongoing questions about effectiveness across cancer types...
IgAN competition heats up: Roche sefaxersen clears phase 3 goal
Roche reported positive phase 3 results for sefaxersen in IgA nephropathy, a move that could increase competitive pressure in a market now crowded with multiple approved therapies. The company...
Biotech and regulatory ecosystem: HHS weighs how to regulate islet cell products for T1 diabetes
HHS is considering whether unmodified islet cells from deceased donors should be regulated as organs for transplant or as biological products for type 1 diabetes. The policy question, framed as a...
Therapy success proof in autoimmune CAR-T: Kyverna reports 1-year miv-cel results
Kyverna Therapeutics reported positive one-year data supporting an FDA submission for miv-cel, its autoimmune CAR-T therapy candidate for stiff person syndrome. The company emphasized durable...
Regulatory approval – oncology therapeutics
The FDA approved Elevar Therapeutics’ Lyrfigtu (lirafugratinib), positioning the oral FGFR2 inhibitor as a second-line option for patients with previously treated, unresectable, locally advanced...
Clinical trial – immunotherapy plus epigenetic strategy in bile duct cancer
A phase 2 trial testing an epigenetic strategy to prime bile duct cancer for immune checkpoint therapy did not generate the intended clinical benefit, according to the study’s report of outcomes...
Capital markets – IPOs in RNA interference
ADARx Pharmaceuticals priced an upsized initial public offering at $446.3 million, adding momentum to 2026’s IPO pipeline for RNA-focused therapeutics. The company began trading on Nasdaq under...
Strategic deals – Roche Genentech expands bispecific discovery with Earendil
Roche’s Genentech inked a discovery collaboration with Earendil Labs for bispecific antibodies in oncology, paying $55 million upfront and setting total potential value above $1.5 billion based on...
Strategic partnership – Envida raises Series E to scale AI plant-and-microbe drug discovery
Enveda Therapeutics raised a $311 million Series E to expand its AI-driven pipeline, pushing additional programs into human testing and later-stage development. The round, led by Catalio Capital...
Regulatory and policy – FDA commissioner nomination and vaccine stance
Heidi Overton, President Trump’s nominee to lead the FDA, reaffirmed in a Senate hearing that the MMR vaccine and the abortion drug mifepristone are safe and effective, while declining to directly...
Cybersecurity and health tech – hospital AI training and data governance
A shared credentialing program signed by UnitedHealthcare (UHC), Cigna and Centene aims to let providers submit information once for multiple health plans. CertifyOS launched the initiative under...
Platform innovation – AI-enabled biopsy planning pilot
Memorial Sloan Kettering researchers ran a pilot study testing whether a chatbot-style AI system could plan liver biopsy needle paths in a controlled setting. The work evaluates the feasibility of...
Clinical oncology diagnostics – multi-cancer blood test scrutiny
FDA advisory panel discussions continued to sharpen the evidence narrative for Grail’s Galleri multi-cancer blood test, with panelists voting that benefits outweigh risks but raising concerns...
Autoimmune CAR-T – long-term safety and efficacy update
Kyverna Therapeutics reported one-year results supporting its autoimmune CAR-T program miv-cel, positioning the candidate as having sustained benefit with an unblemished safety profile while peers...