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.

US Partial Clinical Hold on Diamyd Phase III Trial Lifted by the FDA
STOCKHOLM, Nov. 28, 2022. Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the confirmatory Phase III trial DIAGNODE-3, evaluating the safety and efficacy of the precision... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 28, 2022 Category: Pharmaceuticals Source Type: clinical trials

BioMarin Announces Advancements in FDA Review of ROCTAVIAN for Adults with Severe Hemophilia A
SAN RAFAEL, Calif., Nov. 24, 2022. BioMarin Pharmaceutical Inc. announced advancements in the U.S. Food and Drug Administration (FDA) review of the Biologics License Application (BLA) of ROCTAVIAN (valoctocogene roxaparvovec AAV gene therapy) for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 24, 2022 Category: Pharmaceuticals Source Type: clinical trials

Palisade Bio is Granted Fast Track Designation from the U.S. Food and Drug Administration for LB1148 for Accelerated Return of Bowel Function following GI Surgery
Carlsbad, CA, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for avoidance of acute and chronic post-surgical complications following gastrointestinal (GI) surgery,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 22, 2022 Category: Pharmaceuticals Source Type: clinical trials

Kineret authorized for emergency use by FDA for the treatment of COVID-19 related pneumonia
STOCKHOLM, Nov. 10, 2022. Sobi today announced that the US Food and Drug Administration has granted Emergency Use Authorization (EUA) for the use of Kineret® (anakinra) for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 10, 2022 Category: Pharmaceuticals Source Type: clinical trials

PT027 Recommended by FDA Advisory Committee as New Rescue Treatment for Asthma
9 November 2022 -- The Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 16 to 1 that the data support a favourable benefit risk assessment for the use of PT027 (albuterol/budesonide) for the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 9, 2022 Category: Pharmaceuticals Source Type: clinical trials

EAGLE-2 and EAGLE-3 Phase III Trials for Gepotidacin Stopped Early for Efficacy Following Pre-Planned Interim Analysis by Independent Data Monitoring Committee
Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years GSK plans to submit a New Drug Application for gepotidacin to the US Food and Drug Administration (FDA) in H1... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 3, 2022 Category: Pharmaceuticals Source Type: clinical trials

GSK Reports Outcome from US FDA Advisory Committee Meeting on Daprodustat for Anemia of CKD
London UK October 27, 2022 -- GSK plc (LSE/NYSE: GSK) today reports that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) supported that the benefit of treatment with daprodustat outweighs the risks... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 27, 2022 Category: Pharmaceuticals Source Type: clinical trials

Noema Pharma Receives FDA Fast Track Designation for Basimglurant
BASEL, Switzerland, October 18, 2022– Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announces that the US Food and Drug Administration (FDA) has granted Fast Track... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 18, 2022 Category: Pharmaceuticals Source Type: clinical trials

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age
NEW YORK& MAINZ, Germany--(BUSINESS WIRE) October 12, 2022 -- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 12, 2022 Category: Pharmaceuticals Source Type: clinical trials

Annovis Bio Announces FDA Authorization to Proceed with Phase 2/3 Trial for Buntanetap in Alzheimer's Disease
BERWYN, Pa., Oct. 6, 2022. Annovis Bio, Inc. ( " Annovis " or the " Company " ), a late-stage clinical drug platform company addressing neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has authorized the Phase... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 6, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Approves New Treatment Option for Patients with ALS
SILVER SPRING, Md., Sept. 29, 2022. The U.S. Food and Drug Administration today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig ' s disease. " This... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 29, 2022 Category: Pharmaceuticals Source Type: clinical trials

Mallinckrodt Announces Submission of 510(k) to the U.S. FDA for Inhaled Nitric Oxide Delivery System
DUBLIN, Sept. 28, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced the submission of a 510(k) premarket notification application to the U.S. Food and Drug Administration... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 28, 2022 Category: Pharmaceuticals Source Type: clinical trials

Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib
LEIDEN, The Netherlands, Sept. 28, 2022.Pharming Group N.V. ( " Pharming " or " the Company " ) announces that the US Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for leniolisib, an oral, selective... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 28, 2022 Category: Pharmaceuticals Source Type: clinical trials

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age
NEW YORK& MAINZ, Germany--(BUSINESS WIRE) September 26, 2022 -- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 26, 2022 Category: Pharmaceuticals Source Type: clinical trials

AVROBIO Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration (FDA) for First Gene Therapy in Development for Cystinosis
Second AVROBIO gene therapy program that has been granted rare pediatric disease... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 20, 2022 Category: Pharmaceuticals Source Type: clinical trials