Search
FDA Approves First Treatment for COVID-19
… ews-events/press-announcements/fda-approves-first-treatment-covid-19 … Español Today, the U.S. Food and Drug Administration … least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be …
FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
… s-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults … Español Today, the U.S. Food and Drug … for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to …
La FDA aprueba el primer tratamiento para el COVID-19
… -announcements/la-fda-aprueba-el-primer-tratamiento-para-el-covid-19 … English Hoy, la Administración de Alimentos y … (aproximadamente 88 libras) para el tratamiento del COVID-19 que requiera hospitalización. Veklury sólo debe …
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
… id-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0 … Today, the U.S. Food and Drug Administration issued an … together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or …
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
… id-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19 … Español Today, the U.S. Food and Drug Administration … together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or …
FDA Insight: Hand Hygiene During COVID-19
… /news-events/fda-insight/fda-insight-hand-hygiene-during-covid-19 … Listen (MP3, 11MB) Dr. Shah welcomes Elizabeth … Regulatory Policy, to talk about hand sanitizers and the COVID-19 pandemic. FDA Insight: Episode 18 – Transcript >> …
La FDA aprueba el primer antiviral de ingestión oral para el tratamiento del COVID-19 en adultos
… -primer-antiviral-de-ingestion-oral-para-el-tratamiento-del-covid-19-en-adultos … Englsh Hoy, la Administración de Alimentos y … para administrarse por vía oral) para el tratamiento del COVID-19 de leve a moderado en adultos con alto riesgo de …
Actualización sobre el coronavirus (COVID-19): La FDA autoriza el uso de anticuerpos monoclonales para el tratamiento del COVID-19
… ress-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-autoriza-el-uso-de-anticuerpos-monoclonales-para … … e imdevimab se administren juntos para el tratamiento del COVID-19 leve a moderado en pacientes adultos y pediátricos (12 …
Partnering with the European Union and Global Regulators on COVID-19
… /fda-voices/partnering-european-union-and-global-regulators-covid-19 … By: Anna Abram, Deputy Commissioner for Policy, … on many scientific and regulatory fronts as part of our COVID-19 response. Anna Abram What has helped drive this …
COVID-19 Supply Chain Update: Importation of Vital Food and Medical Products
… and public health officials across the country, to combat COVID-19. A critical part of the FDA’s work is ensuring the safety … our health care workers and hospitals need to battle COVID-19 come from overseas, which makes the FDA’s Office of …
The Critical Role of Health Care Professionals During the COVID-19 Pandemic - 08/10/2020
… da-officials/critical-role-health-care-professionals-during-covid-19-pandemic-08102020 … (Remarks as prepared for delivery) … to have the opportunity today to speak with you about COVID-19, the FDA’s role in responding to this public health …
Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19
… apy-development-and-access-remain-top-fda-priorities-during-covid-19 … By: Patrizia Cavazzoni, M.D., Acting Director, Center … ever as these patients are among the most vulnerable to COVID-19, either directly or indirectly. Many rare disease …
FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns
… onoclonal-antibodies-treatment-and-post-exposure-prevention-covid-19 … Español Today, the U.S. Food and Drug Administration … together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including …
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
… ovid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19 … English Today, the U.S. Food and Drug Administration … therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is …
FDA In Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities
… experience of people with cancer who have contracted COVID-19 is an essential resource that can help the medical … are at an increased risk of more serious outcomes from COVID-19 but also that there are inequities for Black …
Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic
… da-voices/bringing-cancer-doctors-perspective-fdas-response-covid-19-pandemic … By: Stephen M. Hahn, M.D., Commissioner of Food … this country, doctors continue to deal with the influx of COVID-19 cases. As a doctor, my heart breaks for the patients …
Actualización sobre el coronavirus (COVID-19): La FDA aprueba el primer tratamiento de COVID-19 para niños pequeños
… ress-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-aprueba-el-primer-tratamiento-de-covid-19-para … English Hoy, la Administración de Alimentos y …
Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19
… ate-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19 … Today, the U.S. Food and Drug Administration issued an … therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age …
Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues
… /news-events/fda-voices/many-important-drugs-approved-2021-covid-19-pandemic-continues … By: Patrizia Cavazzoni, M.D., … in 2021 despite challenges brought on by the ongoing COVID-19 pandemic. These new approvals, spanning a wide range …
Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies
… /news-events/fda-voices/lessons-learned-covid-19-are-informing-preparation-future-public-health-emergencies … is planning for the federal Public Health Emergency for COVID-19 declared under the Public Health Service Act to expire on …
Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults
… 9-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain … Español Today, the U.S. Food and Drug … for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct …
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment
… -19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment … Español Today, the U.S. Food and Drug … for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe …
Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19
… warning letters to seven companies for selling fraudulent COVID-19 products. These products are unapproved drugs that pose … their response in protecting Americans during the global COVID-19 outbreak. The warning letters are the first to be …
FDA to Discuss COVID-19’s Impact on Medical Product Operations at SBIA REdI Annual Conference
… Acting Commissioner of Food and Drugs In the face of the COVID-19 pandemic, the U.S. Food and Drug Administration has worked … an overview of our regulatory operations during COVID-19. The annual event, which will run July 19-23, 2021, marks …
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19
… /news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19 … Español Today, the U.S. Food and Drug Administration …