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An advisory panel said Quizartinib’s application was missing data needed to make a case for treating adults with relapsed or refractory acute myeloid leukemia. Read More
The FDA should limit or at least spell out the different kinds of covariates allowed in randomized trials, a pair of drug industry giants told the agency. Read More
The FDA released draft guidance on Monday on the content and formatting of Instructions for Use (IFU) for prescription drugs, biologics, and drug- or biologic-device combinations. Read More
The FDA flagged the importance of abuse and dependence labeling for prescription drugs and biologics in a new draft guidance issued Monday — calling them key factors in the agency’s drug reviews. Read More
Glenmark Pharmaceuticals said it is “confident” that it can get its investigational allergy spray Ryaltris back on track after the FDA pulled the brakes on its application in the form of a complete response letter. Read More
The FDA released final guidance for sponsors of drugs to treat or prevent serious flare-ups of skin disorders known collectively as epidermolysis bullosa (EB). Read More
The agency wants to see risk information on serious eye disorders that can result from unintended exposure to the drug and the potential for severe local skin reactions. Read More
CBER released an updated list of guidances it plans to publish this year, including draft recommendations on the following gene therapy topics: Read More