Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Education Secretary Miguel Cardona speaks during a press briefing at the White […]
(Reuters) – Antibodies induced by the Moderna Inc and Pfizer Inc/BioNTech vaccines are dramatically less effective at neutralizing some of the most worrying coronavirus variants, a […]
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Women with polycystic ovary syndrome (PCOS) face an almost 30% increased risk […]
FDA has approved Arcalyst (rilonacept) injection to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 years and older. Recurrent pericarditis […]
NEW YORK (Reuters Health) – Remdesivir reduces the presence of Ebola virus RNA in the semen of Ebola survivors, according to results of the PREVAIL IV […]
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
The Drug Safety-related Labeling Changes (SrLC) database includes updates to safety information in labeling for human prescription drugs regulated under NDAs and human prescription biological products […]
Today, the U.S. Food and Drug Administration authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each […]
Image By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs and Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs Over the past year, the […]
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