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(Reuters) – Pfizer Inc said on Wednesday the U.S. Food and Drug Administration (FDA) had extended the review of its experimental atopic dermatitis drug by three months, the latest regulatory setback for a class of
FILE PHOTO: A screen displays the share price for drugmaker AbbVie on the floor of the New York Stock Exchange July 18, 2014. REUTERS/Brendan McDermidAbbvie Inc said the U.S. Food and Drug Administration has extended
CHICAGO (Reuters) – Results of AstraZeneca Plc’s U.S. COVID-19 vaccine trial are being reviewed by independent monitors, and emergency authorization could come in about a month, a top U.S. official said on Monday. The independent
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. At-home testing for COVID-19 features great convenience, but pathology experts caution that false positives, false negatives, out-of-pocket costs, and the potential
FDA Approves Fotivda (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma BOSTON–(BUSINESS WIRE) March 10, 2021 — AVEO Oncology (Nasdaq: AVEO) today announced that the U.S. Food and
(Reuters) – Abbott Laboratories said on Friday that the U.S. Food and Drug Administration granted emergency use authorization for its molecular test to detect and distinguish the coronavirus and two types of flu viruses in
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. An FDA advisory panel lent their support today to a rapid clearance for Janssen/Johnson & Johnson’s COVID-19 vaccine. The Food and
CAMBRIDGE, Mass. and TOKYO, Nov. 06, 2020 (GLOBE NEWSWIRE) — Today, the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted 1 yes, 8 no and 2 uncertain on
FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients PAOLI, Pa., — (BUSINESS WIRE) — November 9, 2020 – Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S.
October 27, 2020 — Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially