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Regulatory approvals
The FDA has approved AbbVie’s next-generation dopamine therapy for Parkinson’s disease, moving tavapadon into the agency’s cleared treatment landscape under the brand Juvmo. The approval targets...
IPO and market financing
ADARx Pharmaceuticals priced its $446.3 million Nasdaq IPO, underscoring renewed appetite for RNA-focused biotechs. The company sold more than 26 million shares at $17—at the top end of its...
Partnerships and licensing (drug delivery)
Novo Nordisk struck a deal worth up to €1.165 billion with Nanexa for its long-acting drug delivery technology, aiming to extend the duration of peptides used across cardiometabolic programs. The...
Oncology—immunotherapy and CAR-T expansion
A comprehensive review highlights how CAR-T cell therapy is pushing beyond blood cancers into solid tumors and autoimmune indications, mapping the approvals and emerging strategies driving the...
Clinical data—drug safety and real-world complications after cell therapy
A large investigation reports that more than half of patients receiving lifesaving cellular therapies experience orthostatic hypotension—a dangerous blood pressure drop upon standing—within their...
Regimen and safety—identifying biomarkers for amiodarone lung toxicity
Researchers applied machine learning to pinpoint a gene associated with amiodarone-induced pulmonary fibrosis (AIPF), targeting a long-standing gap in early biomarkers for lung scarring. The brief...
Oncology—imaging and recurrence risk tools
Researchers combined MRI and blood markers to identify pancreatic cancer patients at higher risk of early recurrence after surgery. The study, published in Holistic Integrative Oncology in the...
Drug development and manufacturing—scaling siRNA formulations
University of Pennsylvania researchers presented a potential manufacturing route for high-concentration, subcutaneous-ready siRNA formulations by addressing membrane fouling and concentration...
FDA and clinical pipeline—IND approvals and rare-disease progress
Prime Medicine received FDA IND approval for PM-647, an investigational in vivo Prime Editor program targeting α-1 antitrypsin deficiency (AATD). The first-in-human phase I/II trial is expected to...
Patent and legal outcomes—biotech disputes
A jury awarded Nektar Therapeutics $90 million in damages in its dispute with Eli Lilly over a fractured licensing deal involving rezpegaldesleukin (rezpeg). The brief states the jury found Lilly...
FDA approvals and product launches
The FDA has cleared AbbVie’s next-generation dopamine therapy for Parkinson’s disease, tavapadon, which will be marketed as Juvmo. The regulator’s approval reflects a shift toward dopamine agonist...
Regulatory approvals for ultra-rare disease medicines
The FDA approved Mirum Pharmaceuticals’ zilurgisertib for ultra-rare soft tissue disease, marking the third treatment in the space. The therapy targets ALK2 and will be marketed as Atebrioz,...
Regulatory and pipeline expansion in oncology (kidney cancer)
Merck expanded the label for Welireg by gaining FDA approval to use the drug in combination with Eisai’s Lenvima for a broader group of kidney cancer patients. The update applies to advanced renal...
Biopharma IPO momentum and market entry for RNAi
ADARx Pharmaceuticals priced its IPO at $446.3 million and begins trading on Nasdaq under the ticker ADRX, continuing a busy year for RNA-focused public-market debuts. The company sold more than...
Biotech financing and deal flow supporting R&D
Novo Nordisk struck an up-to-€1.165 billion global exclusive license deal with Nanexa AB, aiming to extend its cardiometabolic pipeline with long-acting injectable drug delivery technology. The...
Biotech disputes and courtroom wins affecting collaboration value
A US jury awarded Nektar Therapeutics $90 million in its dispute with Eli Lilly over a fractured licensing deal tied to rezpegaldesleukin, according to reports from the US District Court. The...
Early-stage gene editing and platform IND milestones
Prime Medicine obtained FDA IND approval for PM-647, an investigational in vivo Prime Editor targeting α-1 antitrypsin deficiency (AATD). The first-in-human Phase I/II trial will evaluate a...
CAR-T and cell therapy pipeline review focus
A new comprehensive review maps how CAR-T cell therapies are pushing beyond hematologic cancers into solid tumors and autoimmune disease. The report highlights the continued growth of CAR-T...
Scientific advance: targeting bacterial persistence in recurrent UTIs
Researchers used organoid and differentiated bladder cell models to show that OM-89 (Uro-Vaxom), long used to help prevent recurrent UTIs, also works directly on bladder epithelial degradation...
Drug discovery platform strategy: mutating bacteriophages at genome scale
University of Otago researchers developed a CRISPR-based method for genome-wide mutagenesis of bacteriophages, enabling systematic disruption of phage genes while keeping essential functions...