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FDA Commissioner Robert Califf responded to questions from members of the House Energy and Commerce Committee this week about the agency’s response to the COVID-19 pandemic, including their concerns about the agency’s ability to oversee the pharmaceutical supply chain. Read More
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 on Thursday to recommend allowing GSK to move forward with a single-arm trial to evaluate its immunotherapy dostarlimab-gxly (dostarlimab) for the treatment of patients with mismatch repair deficiency/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer (LARC). Read More
Drugmakers have asked for several clarifications in the draft guidance the agency released in December on the use of statistical approaches in bioequivalence (BE) studies.
A Florida district judge said Tuesday that the nearly 50,000 complaints filed against multiple drugmakers alleging Zantac (ranitidine) causes cancer cannot form larger multi-plaintiff injury cases and must proceed individually.
The European Medicines Agency’s (EMA) policy on interchangeability of biosimilars relates only to the active substance and formulated product, the agency said in a clarifying statement.
The U.S. Court of Appeals for the District of Columbia has rejected petitions from a cohort of drug and devicemakers that seek to overrule a decision last year allowing to proceed a lawsuit accusing the companies of indirectly funding terrorist acts in Iraq. Read More
A federal court has rejected a lawsuit from the Pharmaceutical Research and Manufacturers of America (PhRMA) filed against HHS that would seek to block states from importing prescription drugs from Canada. Read More
In his State of the Union address on Tuesday night, President Biden continued pressing for a $35-per-month limit on insulin for diabetics of all ages. Read More
Drugmakers have a long way to go when it comes to fulfilling their required postmarket reporting, according to the FDA’s most recent numbers. Read More