Regulatory Affairs News Channel

Califf, FDA top officials call for sweeping review of agency opioids policies

FDAIn 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.

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FDA approves first drug to show survival benefit in liposarcoma

FDAThe 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).

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Human medicines: highlights of 2015

EMAThe 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.

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FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients

The U.S. Food and Drug AdministrationToday, 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.

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FDA approves Opdivo to treat advanced form of kidney cancer

The U.S. Food and Drug AdministrationThe 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.

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FDA approves new treatment for HIV

The U.S. Food and Drug AdministrationThe 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.

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FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration has granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa's blood-thinning effects.

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