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FDA approvals in oncology and rare disease
The FDA approved Elevar Therapeutics’ Lyrfigtu (lirafugratinib) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or other rearrangement,...
RNAi IPO debut and public-market momentum
ADARx Pharmaceuticals priced its $446.3 million IPO, adding to 2026’s rapid biotech public-market pace. The RNAi specialist sold 26.25 million shares at $17 apiece and began trading on Nasdaq...
Big dealmaking: Lilly expands China reach with InnoCare pact
Eli Lilly signed a discovery-stage collaboration with Beijing-based InnoCare Pharma, a deal valued at up to $3.35 billion. The partnership is designed to identify and advance compounds against as...
CAR T in rare autoimmune disease: Kyverna gains durable signal
Kyverna Therapeutics reported one-year results supporting its FDA submission pathway for an autoimmune CAR-T program in stiff person syndrome. The data add to the durability narrative for rare...
Lilly-Nanexa delivery deal ties to longer-acting obesity injectables
Novo Nordisk struck a deal with Nanexa worth up to €1.165 billion (about $1.325 billion) for a global exclusive license to Nanexa’s long-acting drug delivery technology. The agreement is...
Chromatography and bioprocessing scale-up via SFC partnerships
Thar Process partnered with ExtrateX to bring prep-to-process-scale supercritical fluid chromatography (SFC) systems to Europe. The arrangement pairs Thar’s Isolator SFC platform for...
Company test-to-market: Prime Medicine’s in vivo Prime Editor clears FDA IND
Prime Medicine received FDA IND approval for PM-647, an investigational in vivo Prime Editor targeting adults with α-1 antitrypsin deficiency (AATD). The company plans a first-in-human Phase I/II...
Drug platform innovation: CRISPR-based genome-wide mutagenesis for phages
Researchers at the University of Otago developed a CRISPR-based approach for genome-wide mutagenesis of bacteriophages, combining transposon insertion sequencing with CRISPR–anti-CRISPR selection....
Biotech litigation: Nektar wins damages in Lilly rezpeg dispute
A US jury awarded Nektar Therapeutics $90 million in its lawsuit against Eli Lilly over a fractured licensing deal involving rezpeg. The amount was below what Nektar sought, but the verdict still...
Clinical pipeline execution: Merck expands Welireg use with FDA approval in kidney cancer
Merck received FDA approval expanding Welireg (belzutifan) to a broader set of kidney cancer patients in combination with Eisai’s Lenvima (lenvatinib). The approval targets patients with advanced...
Regulatory approval: Onswik once-weekly insulin pen clears FDA
Eli Lilly’s once-weekly basal insulin shot, Onswik (insulin efsitora alfa-gobe), won U.S. FDA approval for patients with type 2 diabetes, setting up direct competitive pressure on Novo Nordisk’s...
Regulatory approval: Merck expands Welireg use for advanced RCC
Merck’s Welireg (belzutifan) received FDA approval for broader use in combination with Eisai’s Lenvima (lenvatinib) to treat certain advanced renal cell carcinoma patients. Merck said the...
FDA decision: Lyrfigtu wins approval for FGFR2 fusion cholangiocarcinoma
FDA approved Elevar Therapeutics’ Lyrfigtu (lirafugratinib) as a second-line treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring...
China-to-Western dealmaking: Lilly signs up to $3.35B with InnoCare
Eli Lilly struck a discovery-stage collaboration with Beijing-based InnoCare Pharma worth up to $3.35 billion, extending Lilly’s China innovation push. Under the agreement, InnoCare will use its...
Biosimilar regulatory roadmap: FDA lays out strategy for interchangeable products
The FDA released a post-workshop strategy document covering Biosimilar User Fee Act (BsUFA) III priorities, including future needs for interchangeable biosimilar development. The agency outlined...
AI-biomed diagnostics: Transparent AI hits 95% accuracy choosing immunotherapy in HNSCC
A study reported a transparent AI model that reached 95% accuracy in selecting between approved PD-1 therapies nivolumab and pembrolizumab for patients with recurrent or metastatic head and neck...
Oncology AI early-warning: CT model flags immunotherapy pneumonitis risk
Researchers at The University of Texas MD Anderson Cancer Center developed an AI model that reads routine chest CT scans to flag lung cancer patients likely to develop immunotherapy-related...
Platform deals: Roche Genentech inks $1.5B bispecific pact with Earendil
Roche’s Genentech agreed a discovery and development collaboration with Earendil Labs focused on oncology bispecific antibodies. Earendil will receive a $55 million upfront payment, with...
Clinical innovation: Prime Medicine PM-647 wins IND for in vivo prime editing in AATD
Prime Medicine received FDA IND approval for PM-647, its investigational in vivo prime editor for α-1 antitrypsin deficiency (AATD). The company plans to initiate a first-in-human Phase I/II trial...
Investment and pipeline finance: Enveda banks $311M Series E for AI-driven drugs
Enveda Biosciences raised $311 million in a Series E, valuing the company at about $2 billion as it pushes an AI-driven plant-and-microbe discovery engine toward clinical execution. The financing...