Tag Archives: FDA

Remel Xpect Flu A&B granted FDA clearance

Thermo-Fisher-Scientific-Inc.

TweetThermo Fisher Scientific, Inc., announced on Monday that its Remel Xpect Flu A&B assay was granted clearance by the FDA for assessing detection of emerging viruses. The Remel Xpect Flu A&B assay is currently able to find culture avian influenza … Read More »

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FDA panel approves four-strain flu vaccines

TweetA U.S. Food and Drug Administration advisory panel on vaccines gave its approval on Wednesday to quadrivalent, or four-strain, flu vaccines that may over time replace current three-strain vaccines. The panel gave its endorsement to a proposal by the World … Read More »

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Egg-free vaccine receives FDA approval for distribution

TweetFlublok, an egg-free flu vaccine developed by the Meriden, Connecticut-based Protein Sciences Corporation, recently received approval for distribution by the U.S. Food and Drug Administration. The vaccine uses the small part of the virus needed for immunity and grows it … Read More »

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FDA unveils global pharmacovigilance initiative

TweetThe U.S. Food and Drug Administration Center for Biologics Evaluation and Research recently launched a new initiative designed to support the Global Vaccine Safety Blueprint Project. The initiative, called “Global Regulatory Utilization of Vaccine Safety Surveillance,” was created under a … Read More »

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Researchers develop vaccine for leishmaniasis

TweetScientists with the U.S. Food and Drug Administration’s Office of Blood Research and Review recently developed a live-attenuated vaccine for visceral leishmaniasis, a tropical disease that infects 12 million people annually. Visceral leishmaniasis is caused by the Leishmania protozoan and … Read More »

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FDA say new TB treatment appears safe and effective

TweetThe U.S. Food and Drug Administration recently announced that a novel drug being developed to treat a drug-resistant form of tuberculosis appears safe. The FDA plans to review the Johnson & Johnson-developed drug bedaquiline for accelerated approval. The agency released … Read More »

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FDA’s role in meningitis outbreak examined

TweetThe role of the U.S. Food and Drug Administration in regulating compound pharmacies has recently come under scrutiny following the outbreak of fungal meningitis that sickened nearly 500 people around the country. By law, compounding pharmacies like the New England … Read More »

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FDA discusses REMS during webinar

Tweet The U.S. Food and Drug Administration held a webinar on Tuesday to discuss the implementation of a risk evaluation and mitigation strategy by physicians, pharmacists and patients. All medicines approved by the FDA go through assessments to determine their … Read More »

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House holds contentious hearing with FDA commissioner