Lilly escalates compounding challenge after finding impurity in Tirzepatide-B12 products
Eli Lilly said testing found an impurity in compounded tirzepatide products mixed with vitamin B12 and urged FDA action.
Bristol Myers Squibb’s Mezigdomide Delivers Progression-Free Survival Benefit in Phase 3 SUCCESSOR-2 Trial
SUCCESSOR-2 is mezigdomide’s first positive Phase 3 study and the CELMoD program’s second. The trial showed a progression-free survival benefit over carfilzomib and dexamethasone alone.
BioNTech sets leadership transition as Sahin and Türeci plan move to new mRNA company
BioNTech said its pipeline and COVID-19 vaccine franchise remain unaffected as its co-founders prepare to move to a new independent mRNA company.
Vertex posts positive week 36 phase 3 IgAN data for Povetacicept
Vertex reported positive Week 36 interim Phase 3 data for povetacicept in IgAN and said it will complete its BLA by the end of March.
Agilent Technologies targets pathology growth with $950 million Biocare Medical acquisition
Agilent’s planned acquisition of Biocare Medical would expand its pathology capabilities and place the business inside its Life Sciences and Diagnostics Markets Group.
FDA updates biosimilar development guidance as review experience accumulates
FDA’s March 9 draft biosimilar guidance could eliminate some three-way PK studies and cut related development costs by up to 50%, or about $20 million.
Xenon’s azetukalner meets Phase 3 endpoint in treatment-resistant focal onset seizures
Xenon Pharmaceuticals reported a 42.7% placebo-adjusted reduction in focal onset seizures at the 25 mg dose of azetukalner in Phase 3, lifting shares to an all-time high.
FDA proposes “plausible mechanism” route for individualized ultra-rare disease drugs
The agency’s “plausible mechanism” framework targets genome editing and RNA-based approaches, and outlines how sponsors can build substantial evidence using clinical data, supported by disease biology, natural-history data, and target confirmation, when randomized trials are not feasible.
Immedica Pharma’s Loargys adds an enzyme-replacement entrant for ultra-rare ARG1-D–related hyperargininemia
On February 23, 2026, the FDA approved Loargys (pegzilarginase-nbln) from Immedica Pharma for hyperargininemia in adults and pediatric patients 2 years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction. ARG1-D affects an estimated 250 people in the U.S.A. Immedica Pharma’s CEO,
FDA approves Vanda’s Bysanti for schizophrenia and bipolar I manic or mixed episodes
On February 20, 2026, the FDA approved Bysanti (milsaperidone) from Vanda Pharmaceuticals (VNDA, Nasdaq) for schizophrenia and for manic or mixed episodes associated with bipolar I disorder in adults. Vanda describes Bysanti as a new chemical entity atypical antipsychotic that is bioequivalent to iloperidone across the therapeutic dosing spectrum, enabling
Moderna-FDA public dispute cools as Administration agrees to review amended mRNA flu vaccine application
FDA agreed to review Moderna’s amended mRNA influenza vaccine application after issuing a refusal-to-file letter. The revised approach splits review by age, with accelerated approval in adults 65 and older contingent on a confirmatory post-marketing study.
Key risk statements from boxed warning on six menopausal HRT labels removed by FDA
The FDA approved labeling changes for six menopausal hormone therapy products, removing certain risk statements from the boxed warning. The agency said the action follows a literature review initiated in November 2025.
Acrotech Biopharma brings a new topical PDE4 option - Adquey - into a crowded eczema market.
On February 12, 2026, the FDA approved Adquey (difamilast 1%) ointment from Acrotech Biopharma for the topical treatment of mild to moderate atopic dermatitis in adults and pediatric patients aged 2 years and older. The commercial question centers on where difamilast can earn durable share against entrenched topicals. Mechanistically, difamilast
Guardant publishes Phase III data on ctDNA detection of residual disease after colon cancer surgery
A phase III study of more than 2,000 patients found post-surgical ctDNA detection was associated with a four- to six-fold increase in recurrence risk, according to Guardant Health.
FDA approves Novocure’s Optune Pax for locally advanced pancreatic cancer
The FDA approved Novocure’s Optune Pax for adults with locally advanced pancreatic cancer through the PMA pathway. The decision was based on a randomized, controlled study with follow-up up to five years.
Cellares secures $257 million Series D to scale automated cell therapy manufacturing
Series D backs global rollout of automated IDMO factories as Cellares targets lower costs, higher throughput, and commercial scale.