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FDA


A sign for the Food and Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Sarah Silbiger | Getty Images A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, CNBC has …

CLOSE From vaccination rates to case counts, here are some important COVID-19 statistics you should know from May 2021. USA TODAY Moderna, one of the three companies authorized to provide COVID-19 vaccines to Americans on an emergency basis, announced Tuesday that it has begun applying for a full license from the Food and Drug Administration. …

What this means for patients: Today, the FDA approved another highly sensitive imaging compound specifically for prostate cancer called 18F-DCFPyL. This is the second such approval in less than six months; in December, the FDA approved 68Ga-PSMA-11 PET. These pioneering new scanning tools will revolutionize prostate cancer detection. Both imaging agents are used to “light …

MONROVIA, Calif.–(BUSINESS WIRE)–Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for sotrovimab (previously VIR-7831), an XmAb®-engineered antibody developed by Vir Biotechnology, Inc. (Vir) and …

Biorez announced that it received FDA 510(k) clearance for two sizes of its BioBrace implant for tendon and ligament procedures. New Haven, Conn.-based Biorez designed its biocomposite soft tissue scaffold for use in a range of surgical procedures to reinforce soft tissue where weakness exists, according to a news release. The implant can be used …

(WLNS-TV) – The FDA approves the Pfizer vaccine for ages 12 and up on Monday. Health experts believe expanding vaccination efforts will help fight the spread of the virus. However, some parents like Andrea Bidlack from Lansing, are against the idea of getting children vaccinated. “We don’t know the true effects especially young people they’re …

For Immediate Release: May 10, 2021 Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA …

Breakthrough device designation from the FDA was granted to technology that combines mRNA analysis technology with artificial intelligence (AI) for the early detection of oral and throat cancers, according to the bioscience company responsible for developing the device, Viome.1 The propriety technology that is coupled with an AI platform may offer a novel method for …

Pfizer’s mRNA two-shot vaccine is currently being used in the US under emergency use authorization (EUA) from the FDA. The companies say 170 million doses of the vaccine have been distributed across the US to date. “We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in …

Menthol cigarettes and other tobacco products at a store in San Francisco in 2018. U.S. health regulators announced a new effort Thursday to ban menthol cigarettes. Jeff Chiu/AP hide caption toggle caption Jeff Chiu/AP Menthol cigarettes and other tobacco products at a store in San Francisco in 2018. U.S. health regulators announced a new effort …