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FDA approval expands treatment options for FGFR2-rearranged bile duct cancer
The FDA has approved Elevar Therapeutics’ FGFR2 inhibitor lirafugratinib (Lyrfigtu) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring an...
FDA-backed decision advances multi-cancer blood test scrutiny
An FDA advisory panel recommended moving Grail’s Galleri multicancer early detection test forward, voting that probable benefits outweigh risks while raising concerns about false reassurance and...
IPO: ADARx prices $446.3M debut to expand RNAi pipeline
ADARx Pharmaceuticals priced a $446.3 million initial public offering, continuing a wave of RNA-focused listings as the company positions its RNA interference platform for expansion beyond liver...
Lilly extends China innovation drive with Innocare discovery-stage deal
Eli Lilly signed a discovery-stage collaboration with Beijing-based InnoCare Pharma worth up to $3.35 billion, continuing the company’s strategy of sourcing oncology and other candidates from...
Drug development and manufacturing: JNC showcases large-pore cellulose media for bigger biologics and viral vectors
JNC used BioProcess International 2026 to highlight Cellufine chromatography media designed for downstream processing of increasingly large and complex modalities. The company focused on a...
Biopharma funding: Enveda raises $311M series E for plant-discovered molecules
Enveda Therapeutics raised a $311 million series E, valuing the company at approximately $2 billion as it advances a pipeline of plant-discovered small molecules for inflammatory and metabolic...
Clinical and regulatory milestone: FDA approval of AATD prime editor PM-647
Prime Medicine obtained IND approval from the FDA for PM-647, its in vivo Prime Editor targeting α-1 antitrypsin deficiency (AATD). The company plans to evaluate a one-time intravenous infusion in...
Healthcare policy and regulation: FDA seeks more clarity on when one pivotal trial is enough
Pharmaceutical companies and industry groups have urged the FDA to provide additional details on when a single pivotal trial plus confirmatory evidence is sufficient to support approval of a new...
Patent litigation: Nektar wins $90M in Lilly rezpeg licensing dispute
A U.S. jury awarded Nektar Therapeutics $90 million plus interest in its lawsuit against Eli Lilly over a fractured licensing deal tied to rezpegaldesleukin (rezpeg). The ruling, issued in the...
Biopharma industry dispute and reputational risk: Lilly targeted after GLP-1 press release language criticism
A new critique has targeted Eli Lilly over the wording of a GLP-1-related press release, with concerns raised about “promotional and emotive” language rather than strictly clinical framing. While...
Regulatory approvals: oncology
The FDA approved Elevar Therapeutics’ FGFR2 inhibitor lirafugratinib (Lyrfigtu) for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring FGFR2...
Major drugmaking dealmaking: China licensing and discovery pacts
Eli Lilly expanded its China innovation push with a discovery-stage collaboration with Beijing-based InnoCare Pharma worth up to $3.35 billion. The deal uses InnoCare’s discovery platform to...
Big pharma partnering: drug delivery technology acquisition
Novo Nordisk entered a deal to add long-acting peptide delivery capabilities to its cardiometabolic franchise, licensing Nanexa AB’s drug delivery technology under a global exclusive agreement....
Judicial outcomes: licensing dispute damages
A U.S. jury awarded Nektar Therapeutics $90 million in damages in its dispute with Eli Lilly over a fractured licensing deal covering the autoimmune disease drug rezpegaldesleukin (rezpeg). The...
Capital markets: RNAi IPO and AbbVie-linked funding
ADARx Pharmaceuticals priced an upsized initial public offering at $446.3 million, marking a major IPO milestone for RNA interference therapeutics. The company sold 26.3 million shares at $17...
FDA approvals: endocrine and pipeline competition
The FDA approved Eli Lilly’s once-weekly basal insulin shot Onswik for patients with type 2 diabetes, giving the company a longer-acting option positioned as an alternative to daily basal...
Clinical-stage oncology updates: pancreatic cancer regimen evidence
A reported series of pancreatic cancer findings outlines progress on novel therapeutic approaches aimed at improving survival in a disease with low overall prognosis. The dataset describes...
Engineering and platform science: optimized phage mutagenesis for antimicrobial resistance
Researchers at the University of Otago developed a CRISPR-based workflow to enable genome-wide mutagenesis of bacteriophages, creating a faster route to uncover essential genes and engineer phages...
FDA/Regulatory policy: when one pivotal trial may be enough
Pharmaceutical industry groups and companies asked the FDA to provide more specifics on when sponsors can rely on a single pivotal trial plus confirmatory evidence for approval of new drugs. The...
Biotech financing: growth-stage plant-discovery drug platform
Enveda Therapeutics raised a $311 million Series E to expand its pipeline of drugs derived from plant-discovered molecules, nearly doubling its valuation to about $2 billion. The round was led by...