FDA Approves Emergency Use of Remdesivir for COVID-19 | Health News
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FDA Approves Emergency Use of Remdesivir for COVID-19 | Health News

By Robin Foster and E.J. MundellHealthDay Reporters (HealthDay) SATURDAY, May 2, 2020 (HealthDay News) — As the U.S. coronavirus death toll neared 65,000 on Friday, the U.S. Food and Drug Administration approved emergency use of the first drug that seems to boost recovery among COVID-19 patients. Remdesivir, Gilead Sciences’ intravenous antiviral medication, is to be […]

China approves two coronavirus vaccines for human trials | China News
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China approves two coronavirus vaccines for human trials | China News

China has approved early-stage human tests for two experimental coronavirus vaccines as it battles to contain imported cases and prevent a second wave of COVID-19.  The experimental vaccines are being developed by a Beijing-based unit of Sinovac Biotech and by the Wuhan Institute of Biological Products, an affiliate of state-owned China National Pharmaceutical Group, state news […]

FDA Approves Trodelvy for Metastatic Triple-Negative Breast Cancer | Health News
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FDA Approves Trodelvy for Metastatic Triple-Negative Breast Cancer | Health News

(HealthDay) THURSDAY, April 23, 2020 (HealthDay News) — Accelerated approval has been granted to Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic triple-negative breast cancer who have received at least two previous therapies, the U.S. Food and Drug Administration announced Wednesday. Approval of Trodelvy, a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, was based on […]

FDA Approves Koselugo for Pediatric Neurofibromatosis Type 1 | Health News
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FDA Approves Koselugo for Pediatric Neurofibromatosis Type 1 | Health News

(HealthDay) TUESDAY, April 14, 2020 (HealthDay News) — Koselugo (selumetinib) has received the first approval for treatment of neurofibromatosis type 1 (NF1) in children ages 2 years and older, the U.S. Food and Drug Administration announced Friday. Approved specifically for patients with symptomatic, inoperable plexiform neurofibromas (PNs), Koselugo, a kinase inhibitor, works by blocking a […]

FDA approves new Saliva Test for Coronavirus
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FDA approves new Saliva Test for Coronavirus

The FDA has granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus, the first such approval granted by the federal agency. The new saliva collection method, which RUCDR developed in partnership with Spectrum Solutions […]

FDA Approves First Rapid Antibody Test for COVID-19
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FDA Approves First Rapid Antibody Test for COVID-19

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center. The U.S. Food and Drug Administration has granted Cellex an emergency use authorization to market a rapid antibody test for COVID-19, the first antibody test released amidst the pandemic. “It is reasonable to believe that your product may be effective in […]

FDA Approves Malaria Drugs to Treat COVID-19, Despite Little Proof They Work | Health News
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FDA Approves Malaria Drugs to Treat COVID-19, Despite Little Proof They Work | Health News

By E.J. MundellHealthDay Reporter (HealthDay) TUESDAY, March 31, 2020 (HealthDay News) — With little evidence that the malaria drugs hydroxychloroquine and chloroquine can prevent or treat COVID-19, the U.S. Food and Drug Administration has given emergency approval to distribute millions of doses of the medicines to hospitals across the country. “These drugs will be distributed […]