Regulatory Affairs News Channel

FDA approves new treatment for inhalation anthrax

FDAOn Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

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Launch of PRIME - Paving the way for promising medicines for patients

EMAThe European Medicines Agency (EMA) has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).

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FDA takes additional action to better understand safety of Essure, inform patients of potential risks

FDAThe U.S. Food and Drug Administration has announced actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.

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FDA providing $2 million in new grants for natural history studies in rare diseases

FDAThe U.S. Food and Drug Administration today announced the availability of $2 million in research grants to fund natural history studies in rare diseases. The aim is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval.

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FDA seeks $5.1 billion total for FY 2017

FDAThe 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.

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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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