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Federal Register

FDA Withdrawing Approval of Sioux Bio Animal Drug

Federal Register notice: FDA withdraws approval of a new animal drug application at the sponsors request because the product is no longer manufactured...

Human Drugs

Genentech Reports Disappointing Phase 3 Tecentriq Results

Genentech says its Phase 3 study IMvigor211 that evaluated Tecentriq (atezolizumab) in people with locally advanced or metastatic urothelial cancer wh...

Human Drugs

Research Criteria for PhRMA Membership

PhRMA adds research requirements to its membership criteria, dropping companies that dont spend enough on research and development of new therapies.

Human Drugs

Study Backs Ketamine as Antidepressant

Researchers say a large-scale population study confirms anecdotal reports of ketamines effectiveness as an antidepressant.

FDA General

Comey Firing Causes Postponement of FDA User Fee Mark-up

Responding to the firing of FBI director James Comey, the Senate Health, Education, Labor, and Pensions Committee postpones a planned mark-up of a bil...

Federal Register

Comments Sought on Revisions to FDA Blueprint for Opioid Prescribers

Federal Register notice: FDA announces the availability of draft revisions to the FDA Blueprint for Prescriber Education for Extended-Release and Long...

Human Drugs

Cancer Drugs Approved Fastest in U.S.: FOCR

Friends of Cancer Research releases updated statistics showing that FDA reviews and approves cancer drugs faster than the European Medicines Agency.

Human Drugs

Fluoroquinolone Antibiotic Issues Not Supported: FDA

FDA says reports that fluoroquinolones may result in retinal detachment, aortic aneurysm or aortic dissection are not supported by patient cases ident...

Human Drugs

Inspection Finds CGMP Deviations at Huron Pharmaceuticals

FDAs Detroit District Office warns Huron Pharmaceuticals about CGMP deviations in the production of active pharmaceutical ingredients.

Human Drugs

FDA Accelerated Approval for EMD Seronos Bavencio

FDA grants accelerated approval to an EMD Serono NDA for Bavencio (avelumab) for certain patients with locally advanced or metastatic urothelial carci...