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KRAS G12C pancreatic cancer regulatory breakthrough
The FDA granted breakthrough therapy designation to Eli Lilly’s next-generation KRAS G12C inhibitor olomorasib for patients with advanced pancreatic cancer whose disease is KRAS G12C–mutant and...
Pluvicto expands earlier-stage prostate cancer use
The FDA approved Novartis’ radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor for men with PSMA-positive metastatic...
Pluvicto approval rivals label expansion reporting
Novartis’ Pluvicto received FDA clearance in an earlier prostate cancer stage, in tandem with an androgen receptor pathway inhibitor, for patients with PSMA-positive metastatic hormone-sensitive...
Curium to buy Lantheus in radiopharma consolidation
Curium Pharma agreed to acquire Lantheus Holdings in a definitive deal valued at up to $8 billion, strengthening both firms’ theranostics and radiodiagnostics footprints. Curium will pay $114.50...
Supernus and Indivior merge to form CNS-focused pharma
Supernus Pharmaceuticals and Indivior announced a tax-free, all-stock merger of equals, combining to create a CNS-focused company under the Supernus name. The companies said the deal is structured...
Sandoz settles US generic antitrust litigation
Sandoz agreed to resolve lingering U.S. antitrust claims over alleged generic drug price-fixing through a pair of settlement agreements. The settlements cover claims brought by 43 U.S. states and...
Inocras raises for clinical WGS expansion in US
Inocras closed a $31 million Series B-3 financing round to expand its whole-genome sequencing offering and clinical footprint in the United States. The company, formerly Genome Insight and a...
Twist Bioscience momentum tied to AI-driven protein discovery
Twist Bioscience reported fiscal Q3 2026 revenue growth of 23% year over year, reaching $118.4 million, driven by continued strength across DNA synthesis, protein solutions, and NGS applications....
CareDx analyst upgrade points to assay label expansion expectations
Craig-Hallum upgraded CareDx to a Buy rating and raised its price target to $64 per share, citing growth drivers tied to reimbursement momentum and assay expansion. The analyst pointed to CareDx’s...
FDA panel skepticism undermines Capricor’s Deramiocel resubmission
Capricor’s Deramiocel faced a major hurdle as an FDA Cellular, Tissue, and Gene Therapies Advisory Committee recommended against approval of the company’s resubmitted biologics license...
Regulatory expansion for radioligand prostate cancer therapy
FDA has expanded the indication for Novartis’ radioligand therapy Pluvicto into an earlier stage of prostate cancer, approving it for PSMA-positive metastatic hormone-sensitive prostate cancer...
Leadership transition at BioNTech as it pivots further into oncology
BioNTech has named Guido Oelkers, formerly CEO of Swedish biopharma Sobi, as its next CEO, continuing the company’s shift from COVID-era mRNA manufacturing toward an oncology-focused...
Clinical trial setbacks in cardiometabolic inflammation
Novo Nordisk’s IL-6 inhibitor ziltivekimab has failed to meet its primary cardiovascular endpoint in the phase 3 ZEUS trial, dashing expectations that lowering inflammation would translate into...
FDA advisory committee signals pushback on Duchenne cardiomyopathy cell therapy
Capricor’s Deramiocel has been rejected again by an FDA advisory committee, with members concluding that the evidence from the HOPE-3 phase 3 trial does not provide substantial effectiveness for...
Radiopharma dealmaking: Curium to acquire Lantheus for $8B
Curium has agreed to buy radiopharma peer Lantheus in an $8 billion deal, expanding scale in radioligand and imaging-focused oncology while reshaping the competitive landscape for...
Generic drug antitrust settlements: Sandoz secures scope resolution in US
Sandoz has agreed to settle key components of long-running US antitrust litigation tied to alleged generic drug price-fixing, reaching agreements with multiple sets of claimants to substantially...
Biotech innovation funding and startup financing: Dash Bio raises $30M
Dash Bio has raised a $30 million Series A led by Oak HC/FT to expand its pharma lab services platform, aiming to provide research and operational support to biotechnology and pharmaceutical...
Genomics tools and earnings: Twist Bioscience grows on DNA, protein and NGS demand
Twist Bioscience reported fiscal Q3 2026 revenue growth of 23% year over year to $118.4 million, driven by double-digit increases across DNA synthesis and protein solutions and its NGS...
Corporate consolidation in CNS-focused neuroscience drugs
Supernus Pharmaceuticals and Indivior have signed an all-stock merger agreement to form a CNS-focused company, combining their marketed neurological and substance-use disorder portfolios. The...
Biopharma corporate risk: Amgen cloud breach affecting patient data
Amgen disclosed that hackers stole company and patient information in a cloud data breach involving data hosted by third-party providers. Amgen said it detected unauthorized activity affecting...