FDA Expands Label for Eli Lilly BTK Inhibitor to Treat Additional Cancer Indications

Eli Lilly announced FDA approval of Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a covalent BTK inhibitor on December 3rd, 2025. This action converts an accelerated approval from December 2023 into a […]

Natera Acquires Foresight Therapeutics in Deal Worth Up To $450 Million

Natera, a biopharmaceutical company specializing in cell-free DNA and precision medicine, announced the acquisition of Foresight Diagnostics, a cancer diagnostics company, on December 4th, 2025. According to a company press release, Natera will pay $275 million in upfront fees for Foresight, with an additional $175 million contingent on revenue and reimbursement-based milestones. The acquisition grants […]

Trevi Therapeutics Announces Appointment of David Hastings as Chief Financial Officer

Trevi Therapeutics, a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced that David Hastings will assume the role of Chief Financial Officer effective January 6, 2026. […]

Dipharma publishes a peer-reviewed study in Organic Process Research & Development: a novel approach to detect and characterize nitrosamine formation in APIs

Dipharma Francis S.r.l., a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients (APIs) and advanced intermediates, proudly announces the publication of the open-access article titled: “Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test” in the scientific journal Organic Process Research & Development (OPR&D). The […]

FDA Grants Otsuka Accelerated Approval for IgAN Treatment

Otsuka Pharmaceutical announced that FDA granted accelerated approval of Voyxact (sibeprenlimab-szsi) as a treatment for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) on November 26th, 2025. According to a company press release, sibeprenlimab-szsi is a self-administered, subcutaneous injection designed to block A-PRoliferation-Inducing-Ligand. This is intended to reduce levels of serum-galactose-deficient […]

EU Approves Regeneron and Sanofi’s Dupixent for Chronic Spontaneous Urticaria

Regeneron Pharmaceuticals and Sanofi announced that the European Commission approved Dupixent (dupilumab) as a treatment for moderate-to-severe chronic spontaneous urticaria (CSU), a chronic inflammatory skin disease, on November 25th, 2025. The therapy is indicated for patients ages 12 and older with inadequate response to histamine-1 antihistamines and who are naïve to anti-immunoglobulin E therapy for […]

Lilly becomes first drugmaker to hit $1 trillion valuation on weight-loss demand

Eli Lilly, hit $1 trillion in market value on Friday, making it the first drugmaker to enter the exclusive club dominated by tech giants and underscoring its rise as a weight-loss powerhouse. A more than 35% rally in the company’s stock this year has largely been driven by the explosive growth of the weight-loss drug […]

Antheia and TAPI Partner to Advance Global Commercialization Strategy for Critical Pharmaceutical Ingredients

Antheia, the pharmaceutical ingredient manufacturer transforming essential medicine supply chains, and TAPI – Technology and API Services, today announced a strategic partnership. Antheia will leverage TAPI’s next-generation fermentation capabilities and manufacturing facilities in Europe to further commercialize its pipeline of biosynthetic key starting materials (KSMs) and active pharmaceutical ingredients (APIs).   This partnership unites Antheia’s […]

Novartis announces plans to build flagship manufacturing hub in North Carolina

Novartis, a leading global innovative medicines company, announced plans to expand its operations in North Carolina, creating a new flagship manufacturing hub with end-to-end manufacturing capabilities. The strategic investment is a major step to ensure all key Novartis medicines for US patients are manufactured in the US and delivered to patients across the country at […]