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The Senate Committee on Health, Education, Labor and Pensions unanimously advanced the Opioid Crisis Response Act (S. 2680) Tuesday but voted down an amendment to impose tough penalties on drugmakers. Read More
Generic drug approvals were in the spotlight during remarks by FDA Commissioner Scott Gottlieb before a Senate appropriations subcommittee on the FDA’s fiscal year 2019 budget request. Read More
The FDA sent Pfizer a complete response letter for its proposed biosimilar of Genentech’s Herceptin (trastuzumab), saying it needs to see more data before approving the breast cancer drug. Read More
The FDA’s Center for Biologics Evaluation and Research published guidance on information to include in biologics license application datasets, including data on clinical trial endpoints and adverse events. Read More
An FDA advisory committee was split on Monday over several questions on Eli Lilly’s rheumatoid arthritis dosage, voting in favor of efficacy for both a 2 mg and 4 mg dosage but voting against the safety and risk-benefit profile of the larger dosage. Read More
The FDA released draft guidance on a “streamlined nonclinical program” for sponsors of nonclinical studies for development of pharmaceuticals for treatment of patients with debilitating or life-threatening hematologic disorders, saying such nonclinical studies should consider general toxicology, pharmacology and reproductive toxicology. Read More