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Incyte needs to complete another clinical trial of its proposed anal cancer treatment retifanlimab before the FDA should consider approving it, an agency advisory committee said Thursday. Read More
Remarks by Acting FDA Commissioner Janet Woodcock about the future of medical research and drug approval resulted in a backlash this week, adding to calls for her resignation from Sen. Joseph Manchin (D-W.V.) and increasing pressure from advocacy groups and federal legislators that she not be made permanent FDA commissioner. Read More
The department withdrew the opinion after the federal Delaware court denied its motion to toss out a lawsuit filed by AstraZeneca over the 340B mandate. Read More
The Supreme Court left intact a ruling that AbbVie’s complaint against Perrigo was filed only to delay a proposed generic version of AbbVie’s testosterone drug AndroGel. Read More
A Centers for Disease Control and Prevention (CDC) expert panel yesterday concluded that there is likely a link between heart inflammation and inoculations with the Pfizer/BioNTech and Moderna COVID-19 vaccines but emphasized that the benefits of the shots greatly outweigh the risks. Read More
A World Health Organization (WHO) expert panel will consider adding 40 new medications to the WHO’s Essential Medicines List (EML) at its annual conference in Geneva over the next two weeks. Read More
Five Blue Cross Blue Shield health insurance plans have set up an independent company aimed at reducing drug costs by linking the prices with actual drug results. Read More
In the first-ever instance of a state and drugmaker reaching a deal over price-fixing litigation, Teva Pharmaceuticals has agreed to fork over $925,000 to the state of Mississippi to settle allegations of conspiring to set prices of generic drugs. Read More
The FDA released two memos from officials and a long review document late Tuesday, shining new light on internal agency discussions over the past two years regarding Biogen’s Aduhelm, the very expensive new Alzheimer’s disease (AD) drug that’s caused a firestorm of controversy since the FDA approved it June 7 against the advice of its 11-member advisory panel, three of whom resigned in protest after the approval. Read More