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May 10, 2019
The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.
May 09, 2019
The new guidance was issued to assist applicants in determining which abbreviated pathway to take for submitting marketing applications.
May 07, 2019
The agency approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients six to less than 17 years of age.
May 03, 2019
The agency is updating its warning requirements for eszopiclone, zaleplon, and zolpidem after reports of complex sleep behaviors.
The agency approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus.
Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
May 01, 2019
The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.
The CHMP has recommended that Sixmo (buprenorphine) be granted a marketing authorization in the EU as a substitution treatment for opioid dependence.
April 18, 2019
CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.
April 17, 2019
AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.