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FDA approvals: FGFR2 fusion cholangiocarcinoma
The FDA has approved lirafugratinib (Lyrfigtu) for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or other rearrangements....
FDA advisory panel backs Grail’s multicancer blood test
Two FDA advisory panel votes moved Grail’s Galleri multicancer early detection blood test closer to agency action. The molecular and clinical genetics devices panel endorsed the test as safe and...
RNAi IPO: ADARx prices $446M offering with AbbVie support
RNA interference specialist ADARx Pharmaceuticals priced a $446.3 million initial public offering and began trading on Nasdaq under the ticker ADRX, after also securing additional investment from...
Strategic finance: Enveda’s $311M Series E for AI-driven nature-derived drugs
Enveda Biosciences raised $311 million in a Series E financing at an approximately $2 billion valuation, expanding funding for its AI-driven, nature-to-molecule drug discovery platform. The round...
Biotech dealmaking: Roche joins discovery sprint with Atavistik and Earendil
Roche expanded its drug discovery dealmaking with separate partnerships with Atavistik Bio and Earendil Labs. In the Atavistik agreement, Roche secured a backloaded $2 billion collaboration to...
Autoimmune CAR-T: Kyverna reports one-year miv-cel data
Kyverna Therapeutics reported one-year clinical data supporting its rare autoimmune CAR-T program, miv-cel, in stiff person syndrome. The company said the results bolster its case for submission...
Immunotherapy innovation: nanoparticles reprogram scar-driving tumor macrophages
A study described a nanoparticle approach that targets scar-driving immune cells to open tumors to immunotherapy. The work focuses on the fibrotic tumor microenvironment—particularly in liver and...
CNS drug discovery: Earendil lands $1.5B Genentech collaboration
Earendil Labs secured a $1.5 billion discovery collaboration with Genentech to develop bispecific antibody therapeutics in oncology. The agreement is Earendil’s second major partnership in 2026...
Bioprocessing: Sartorius NMPC boosts continuous CHO perfusion productivity
Sartorius researchers unveiled a nonlinear model predictive control framework intended to improve fully continuous CHO perfusion runs. In reported digital twin experiments, the approach...
Regulatory leadership: FDA nominee Heidi Overton affirms vaccine and mifepristone safety
At her Senate confirmation hearing for FDA commissioner, Heidi Overton said she would follow the law regarding vaccine and mifepristone decisions and affirmed both as safe and effective based on...
FDA advisory panel backs Grail’s multi-cancer blood test
An FDA advisory panel backed Grail Inc.’s Galleri multi-cancer early detection blood test, voting that benefits outweigh risks and clearing a key hurdle toward potential premarket approval. The...
FDA decision: Elevar’s lirafugratinib approved for FGFR2-rearranged bile duct cancer
The FDA approved Elevar Therapeutics’ Lyrfigtu (lirafugratinib) for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or other...
Lilly expands China innovation pipeline via InnoCare deal
Eli Lilly signed a new China discovery-stage pact with InnoCare Pharma, extending its run of large partnerships to source oncology and other drug innovation from China. The agreement spans up to...
Kyverna reports 1-year durability data for autoimmune CAR-T
Kyverna Therapeutics reported one-year data supporting durability for its autoimmune CAR-T candidate miv-cel in stiff person syndrome. The company framed the results as bolstering an FDA...
FDA advisory spotlight on Overton’s confirmation – vaccines and mifepristone under Senate scrutiny
Heidi Overton, President Trump’s nominee to lead the FDA, faced repeated questions at a Senate hearing on vaccines and the abortion drug mifepristone. Overton told lawmakers she would follow the...
Elephants in the room: Merck’s Brunello DME study lifts Wnt strategy while analysts weigh safety
Merck reported positive top-line results from the pivotal Phase IIb/III Brunello trial of remigromig in adults with diabetic macular edema, reporting noninferiority versus active control on key...
Novo and Lilly rivalry: FDA approves Eli Lilly’s once-weekly insulin pen
The FDA approved Eli Lilly’s once-weekly basal insulin pen, Onswik, for patients with type 2 diabetes, setting up direct competition with Novo Nordisk’s weekly insulin franchise. Lilly has...
Biopharma financing and platform momentum: Enveda’s $311M Series E
Enveda Biosciences raised $311 million in a Series E financing to advance its AI-driven drug discovery pipeline, including three oral drug candidates in clinical trials and two programs with...
Sarepta settles Regenxbio gene therapy claims; continues gene-therapy legal and funding landscape
Sarepta Therapeutics agreed to pay Regenxbio $39 million to settle gene therapy-related claims, underscoring ongoing legal and financial friction in the gene therapy space even after clinical...
FDA approvals in oncology
The FDA has approved lirafugratinib (Lyrfigtu) for adults with previously treated, unresectable or metastatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements, based on the...