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.
Affinia cites low-dose engineered capsid strategy as AFTX-201 receives Fast Track
The company says AFTX-201 is designed for cardiac transduction at 5- to 10-fold lower doses than conventional capsids, with preclinical studies in a disease model cited as restoring cardiac function.
Twenty-seven years to one drug: How failure defined Cytokinetics before Aficamten
Aficamten delivered Cytokinetics’ first commercial validation, yet the path exposed operational friction, from timing to regulatory fluency.
FDA greenlights Ascendis’ once-weekly YUVIWEL to boost growth in children with achondroplasia
On February 27, 2026, the FDA approved Ascendis Pharma’s YUVIWEL (navepegritide) (ASND, Nasdaq, Close: $233.50 - as of Feb. 27, 2026) to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. Navepegritide is a once-weekly subcutaneous C-type natriuretic peptide prodrug.
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, Anders Edvell,
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.