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Microgravity offers unique advantages when investigating cells and proteins, but collaboration and a strong ethical framework are needed to fully realize its benefits. -
FDA Roundup: January 2, 2024
1/2/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs
12/26/2023
Jemincare announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration and 2 approvals from the U.S. Food & Drug Administration.
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Now designated as a Tech Hub by the White House, Alabama’s nonprofit Southern Research is winnowing its focus and investing in healthcare solutions.
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FDA Roundup: December 22, 2023
12/22/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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The European Commission upheld exclusive marketing protection in Europe for Biogen’s multiple sclerosis therapy Tecfidera until February 3, 2025, staving off generic competition. -
Perfuze® Announces FDA Clearances for Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment
12/20/2023
Perfuze, a private medical device company dedicated to developing pioneering technology to treat acute ischemic stroke, proudly announces FDA clearance for the Millipede 070 Aspiration Catheter and the 2nd generation of the Millipede 088 Access Catheter.
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FDA Roundup: December 19, 2023
12/19/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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President Joe Biden has long promised to stand up to Big Pharma, lower prescription drug prices and limit the power of drugmakers—a pledge he seems intent on keeping. -
At the urging of the Biden administration, Sanofi and AstraZeneca are pledging 230,000 additional doses of their respiratory syncytial virus infant immunization Beyfortus in January 2024.
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FDA Roundup: December 15, 2023
12/15/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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The Biden administration on Thursday said 48 drugs covered under Medicare’s Part B may be subject to inflation rebates in the first quarter of 2024 under the Inflation Reduction Act.
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Joint Federal Operation Results in Seizure of More Than $18 Million in Illegal E-Cigarettes
12/14/2023
The U.S. Food and Drug Administration, in collaboration with U.S. Customs and Border Protection, announced the seizure of approximately 1.4 million units of unauthorized e-cigarette products, including brands such as Elf Bar, which according to the 2023 National Youth Tobacco Survey, is the most commonly used brand among youth e-cigarette users.
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FDA Warns Nine Manufacturers, Distributors of Unapproved Antimicrobials for Animals
12/14/2023
The U.S. Food and Drug Administration is announcing the issuance of nine warning letters to manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs for violations of federal law.
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Medicines on the list can still be prescribed but will be under tight monitoring by a regulatory network, which can implement measures to prevent shortages and ensure supply chain continuity. -
FDA Advances Reorganization Proposal for Unified Human Foods Program, Field Operations and Additional Modernization Efforts
12/13/2023
The U.S. Food and Drug Administration is providing an update on its efforts to create a unified Human Foods Program and new Office of Regulatory Affairs model, including additional details about the proposed structure, status of activities and timeline for next steps.
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FDA Roundup: December 8, 2023
12/8/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Following a nine-month review, the Biden administration will issue a framework for the National Institutes of Health to implement so-called “march-in rights” under the Bayh-Dole Act of 1980. -
Quest Diagnostics and CDC Expand Public Health Research Collaboration to Better Understand Hepatitis C Burden in the United States
12/7/2023
Quest Diagnostics announced that it has been awarded a contract by the United States Centers for Disease Control and Prevention designed to assess the burden of hepatitis C virus in the United States
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With the biopharma industry’s looming wave of gene therapy submissions and potential approvals, the senior senator is laying the groundwork for a legislative initiative to improve access to these expensive treatments.