Food and Drug Administration (FDA) Clinical Trials This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Pfizer and BioNTech Granted FDA Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster
NEW YORK and MAINZ, GERMANY, August 31, 2022— Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 31, 2022 Category: Pharmaceuticals Source Type: clinical trials

Moderna Completes Application To U.S. Food And Drug Administration For Emergency Use Authorization Of Omicron-Targeting Bivalent Covid-19 Booster Vaccine, mRNA-1273.222
mRNA-1273.222 Targets BA.4/BA.5 Strains of Omicron Variant Pending Authorization, Moderna Ready to Ship Bivalent Booster mRNA-1273.222 in September Clinical Data Available for Moderna ' s Bivalent COVID-19 Booster Vaccines Have Met All Primary... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 23, 2022 Category: Pharmaceuticals Source Type: clinical trials

U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
TOKYO, Aug. 18, 2022. Astellas Pharma Inc. ( " Astellas " ) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ' s New Drug Application (NDA) for fezolinetant, an investigational oral, nonhormonal compound seeking... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 18, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Lifts Partial Clinical Hold on the TakeAim Lymphoma Study of Emavusertib
LEXINGTON, Mass., Aug. 18, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 18, 2022 Category: Pharmaceuticals Source Type: clinical trials

GenFleet Receives FDA Approval for Phase II Study of RIPK1 Inhibitor GFH312
Aug 18, 2022 -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has approved the clinical trial application for GFH312 in a... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 18, 2022 Category: Pharmaceuticals Source Type: clinical trials

Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older
Basel, 12 August 2022 - Roche today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 12, 2022 Category: Pharmaceuticals Source Type: clinical trials

Monkeypox Update: FDA Authorizes Emergency Use of Jynneos Vaccine to Increase Vaccine Supply
August 09, 2022 -- Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Jynneos vaccine to allow healthcare providers to use the vaccine by intradermal injection for individuals 18 years of age and older... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 9, 2022 Category: Pharmaceuticals Source Type: clinical trials

Relmada Therapeutics Receives FDA Fast Track Designation for REL-1017 as a Monotherapy for the Treatment of Major Depressive Disorder
CORAL GABLES, Fla., Aug. 9, 2022. Relmada Therapeutics, Inc., a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 9, 2022 Category: Pharmaceuticals Source Type: clinical trials

AbbVie Submits Regulatory Applications to FDA and EMA for Rinvoq in Crohn's Disease
NORTH CHICAGO, Ill., July 27, 2022. AbbVie today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (Rinvoq 45 mg [induction dose] and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 27, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Authorizes Pharmacists to Prescribe Paxlovid
WEDNESDAY, July 20, 2022 -- Today, the U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 20, 2022 Category: Pharmaceuticals Source Type: clinical trials

Escend Pharmaceuticals, Inc., Receives IND Clearance from the FDA for ES-3000 Phase I Study in Relapsed or Refractory Acute Myeloid Leukemia
MENLO PARK, Calif., July 15, 2022. Escend Pharmaceuticals, Inc., a privately held company focused on the development of small molecule therapeutics for oncology orphan diseases, announced today that the United States Food and Drug Administration... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 15, 2022 Category: Pharmaceuticals Source Type: clinical trials

Hookah Additive Research to Inform Product Standards
Condition: Tobacco-Related Carcinoma Interventions: Other: Questionnaire Administration; Behavioral: Tobacco Smoking Sponsors: Ohio State University Comprehensive Cancer Center; Ohio State University College of Public Health; National Cancer Institute (NCI); Food and Drug Administration Center for Tobacco Products Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 12, 2022 Category: Research Source Type: clinical trials