Trump congratulates the FDA as it green lights Moderna’s COVID-19 vaccine: US authorizes second shot in seven days and readies…
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Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 30, 2020– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a…
Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization
TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered…
FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis
NEW YORK–(BUSINESS WIRE) October 27, 2020 — Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration…
FDA establishes Digital Health Center of Excellence
The FDA announced today the launch of the Digital Health Center of Excellence, a central resource intended to help the…
FDA Approves Palforzia
FDA Approves Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] as First Treatment for Peanut Allergy BRISBANE, Calif.–(BUSINESS WIRE)–Jan. 31, 2020– Aimmune…
FDA committee: Makena should be removed from market
Makena, a drug used to reduce the risk for preterm births, should be taken off the U.S. market, a U.S.…
Here are the drugs the FDA says are OK to take in place of recalled Zantac
Walmart joins other retailers in removing the antacid Zantac from stores, ATM fees reach record high Fox Business Briefs: Stores…
Medtronic recalls some insulin pumps as FDA warns they could be hacked
(HealthDay)—The U.S. Food and Drug Administration announced Thursday that some high-tech insulin pumps made by Medtronic are being recalled for…
Moleculin Files with FDA for Expedited Approval Pathway for Annamycin
HOUSTON, TX / ACCESSWIRE / March 13, 2019 / Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical…