Regulatory strategies, submissions, and compliance
BeiGene announced that BEQALZI™ (sonrotoclax) received accelerated approval from the U.S. FDA on May 13, 2026. This approval is for the treatment of adult patients with relapsed or refractory mantle c...
Ionis Pharmaceuticals announced positive topline results from its pivotal Phase 1-3 study of zilganersen for Alexander disease (AxD), a rare and often fatal neurological condition.
BeOne Medicines Ltd. (BGNE) filed an 8-K on April 14, 2026, pertaining to its 2025 Annual Report filed with the Shanghai Stock Exchange's STAR Market.
Ionis Pharmaceuticals announced significant changes to its Board of Directors. B. Lynne Parshall and Joseph H. Wender will retire at the end of their terms in June 2026.
Moderna, Inc. announced in an 8-K filing that the FDA issued a Refusal-to-File (RTF) letter for its Biologics License Application (BLA) for mRNA-1010, its investigational seasonal influenza vaccine.
Piper Sandler Companies (PIPR) announced the appointment of Stuart M. Essig to its Board of Directors, effective February 4, 2026.
Regeneron Pharmaceuticals announced its fourth quarter and full year 2025 financial results, showcasing revenue growth driven by Dupixent and EYLEA HD. Q4 revenues increased 3% to $3.
AbbVie reported its full-year and fourth-quarter 2025 financial results, showcasing strong growth driven by its immunology portfolio, particularly Skyrizi and Rinvoq.