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.
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.
Slone Partners’ Leslie Loveless on the post-boom talent reset in biopharma
Biopharma’s boom-era org charts are giving way to leaner, faster operating models. Slone Partners CEO, Leslie Loveless, says the edge now goes to pragmatic builders: “The companies that win right now are hiring leaders who can do more with less.”
A national prostate screening programme would do more than detect cancer
Prostate screening could be some men’s only NHS touchpoint in years. With public role models shifting stigma, it should be treated as early detection and a route back into routine care.
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
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.
FDA approvals - January 2026
Copper replacement formalizes care for a fatal pediatric metabolic disorder.
Why Flatiron is betting on data quality, not hype, to power the next era of cancer care
With global oncology scale and nearly 2,000 scientific publications, Flatiron Health is positioning itself as the industry’s most trusted evidence partner by pairing AI-driven speed with uncompromising scientific rigor. “We don’t chase hype. We build trust, and in healthcare that’s non-negotiable.”