Aldeyra receives FDA complete response letter for Reproxalap
The FDA issued a Complete Response Letter for Aldeyra’s reproxalap application in dry eye disease, citing insufficient evidence of efficacy and inconsistent trial results.
Biotech & Life Sciences
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Johnson & Johnson’s ICOTYDE brings a new oral IL-23 option to plaque psoriasis
On March 17, 2026, the FDA approved Johnson & Johnson’s ICOTYDE (icotrokinra) for adults and pediatric patients 12 years and older who weigh at least 40
FDA approves Alfasigma’s Lynavoy for primary biliary cholangitis
On March 17, 2026, the US FDA approved Lynavoy (linerixibat) for cholestatic pruritus associated with primary biliary cholangitis. The approval came days after GSK and Alfasigma announced
Novartis expands Cosentyx label with FDA approval in adolescent Hidradenitis Suppurativa
The FDA approval extends Cosentyx into pediatric hidradenitis suppurativa, with use supported by adult studies, pharmacokinetic modeling, and pediatric data from other approved indications
China approves commercial BCI system for cervical spinal cord injury patients
The approved NEO system is designed to restore hand-grasping ability through neural signal decoding and a robotic glove.
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.
Aldeyra's reproxalap receives a third FDA rejection for dry eye disease as inconsistent trial results undermine efficacy case
The third CRL in three years cites a lack of substantial evidence of efficacy for the RASP inhibitor eye drop, with the FDA pointing to inconsistent results across trials
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.
