FDA seeks $5.1 billion total for FY 2017
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- Category: FDA
The U.S. Food and Drug Administration is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President's fiscal year (FY) 2017 budget - an eight percent increase over the enacted budget for FY 2016.
Califf, FDA top officials call for sweeping review of agency opioids policies
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- Category: FDA
In response to the opioid abuse epidemic, today Dr. Robert Califf, the FDA's Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency's approach to opioid medications.
FDA approves first drug to show survival benefit in liposarcoma
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- Category: FDA
The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic).
Human medicines: highlights of 2015
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- Category: EMA
The European Medicines Agency (EMA) has released an overview of its 2015 key recommendations in relation to the marketing authorisations of new medicines and the safety monitoring of authorised medicines.
FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients
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- Category: FDA
Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency. Patients with LAL deficiency (also known as Wolman disease and cholesteryl ester storage disease [CESD]) have no or little LAL enzyme activity.
FDA approves Opdivo to treat advanced form of kidney cancer
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- Category: FDA
The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.
FDA approves new treatment for HIV
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- Category: FDA
The U.S. Food and Drug Administration has approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
More Pharma News ...
- FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa
- FDA approves new injectable drug to treat schizophrenia
- FDA approves Keytruda for advanced non-small cell lung cancer
- EMA's medical literature monitoring enters into full operation
- FDA approves first treatment for sexual desire disorder
- FDA takes action to protect consumers from potentially dangerous counterfeit medicines and devices sold online
- FDA approves anti-clotting drug Savaysa