Policy
In a Cabinet meeting, Health Secretary Robert F. Kennedy Jr. said the website could go live “probably in the next 10 days,” but an exact launch date remains unclear.
FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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Because of the potential for significant side effects of CAR-T therapies, the FDA requires Risk Evaluation and Mitigation Strategies (REMS) programs. The Bezos Family Immunotherapy Clinic at the Seattle Cancer Care Alliance is one of those approved sites.
The U.S. Food and Drug Administration withdrew its draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars.
U.S. District Judge in Philadelphia came down on the side of the Federal Trade Commission (FTC) in an anti-trust lawsuit filed in 2014 against AbbVie and its partner Besins Healthcare. They are ordered to pay $448 million.
A recent change to the definition of “smaller reporting company” by the U.S. Securities and Exchange Commission earned praise from the Biotechnology Innovation Organization.
It’s a big week for the U.S. Food and Drug Administration (FDA) with plenty of upcoming decisions including Achaogen, GW Pharma, Merck and more.
The scope of the U.S. Food and Drug Administration’s mission could become much narrower if a proposed restructuring of the federal government comes to fruition.
The first company has provided a potential out-of-pocket price for patients who seek access through the recently passed federal Right-to-Try legislation and it’s not cheap.
Robert Gadimian, a former executive with Puma Biotechnology, was sentenced to more than two years in prison for insider trading.
Sunny Balwani intends to fight not only the criminal charges, but is also fighting the charges brought by the SEC.
The U.S. Patent and Trademark Office (USPTO) granted Emmanuelle Charpentier, co-founder of ERS Genomics, the University of California and University of Vienna, their first U.S. patent covering the use of CRISPR/Cas9 for gene editing.