News
The FDA will close out April with five target action dates around indications that include pediatric seizures and a neurological cancer in children.
FEATURED STORIES
Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
Job Trends
Ultragenyx Pharmaceutical Inc. reported preliminary unaudited 2021 Crysvita® revenue in Ultragenyx territories and Dojolvi® global revenue, cash and investments at year end 2021, and provided 2022 revenue guidance for Crysvita in Ultragenyx territories and Dojolvi globally.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
THE LATEST
The acquisition of the privately-held company will bring its novel, investigational beta-lactamase inhibitors and other antimicrobials into the Japanese pharma’s pipeline.
FibroGen takes another hit as its antibody hopeful fails in a second indication. The biopharma says that it is cutting costs to extend its cash runway.
A year after treatment, Vertex’s VX-880 has eliminated the need for insulin injections in two Type 1 diabetes patients in a Phase I/II clinical trial of its investigational stem cell-based therapy.
New Phase II data, published in the New England Journal of Medicine, showed Lilly’s oral GLP-1 receptor agonist orforglipron induced nearly 15% weight loss in obese and overweight adults.
CMS has stated that it will cover new Alzheimer’s drugs if the therapies are fully approved. But significant financial questions remain.
Results of a Phase IIb trial of the company’s anti-TL1A antibody showed more than a third of ulcerative colitis patients entered remission while receiving the experimental treatment.
Banking on its lead antibody APG777 for atopic dermatitis, Apogee Therapeutics is filing an initial public offering for an as-yet-undisclosed value.
A day after the FDA denied Intercept’s application for its non-alcoholic steatohepatitis treatment, the pharma announced it has axed all NASH investments and one-third of its staff.
Citing anti-trust issues, six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are joining the FTC’s legal challenge to Amgen’s nearly $27.8 billion buyout of Horizon.
Regeneron envisions new dosing for Eylea’s label and it’s the moment of truth for BioMarin’s gene therapy for hemophilia A. For that and more, see inside.