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 Submit for U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years
NEW YORK and MAINZ, GERMANY, March 1, 2023— Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster (fourth) dose... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 1, 2023 Category: Pharmaceuticals Source Type: clinical trials

Pfizer Receives Positive FDA Advisory Committee Votes Supporting Potential Approval for Vaccine Candidate to Help Combat RSV in Older Adults
NEW YORK--(BUSINESS WIRE) February 28, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that available data is... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 28, 2023 Category: Pharmaceuticals Source Type: clinical trials

Beactica Therapeutics Receives FDA Orphan Drug Designation for BEA-17 for the Treatment of Glioblastoma
UPPSALA, Sweden, Feb. 1, 2023 /PRNewswire/ -- Beactica Therapeutics AB, the Swedish precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BEA-17 for the treatment of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 1, 2023 Category: Pharmaceuticals Source Type: clinical trials

Update on US Food and Drug Administration Emergency Use Authorisation of Evusheld
26 January 2023 -- The US Food and Drug Administration (FDA) has stated that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorised for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 26, 2023 Category: Pharmaceuticals Source Type: clinical trials

Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease
TOKYO, Jan. 20, 2023. Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on January 19th for the FORTIS Ph1/2 clinical... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 20, 2023 Category: Pharmaceuticals Source Type: clinical trials

U.S. Food and Drug Administration Issues Complete Response Letter for Accelerated Approval of Donanemab
Accelerated approval application was based on Phase 2 trial showing amyloid plaque lowering Complete response letter based on limited number of patients with 12-month drug exposure data in the accelerated approval submission; no other... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 19, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Clears Application for Phase 2 Clinical Trial of CYR-064 to Treat Post-Viral Smell Loss
DELRAY BEACH, Fla., Jan. 18, 2023. Cyrano Therapeutics, a biopharmaceutical company developing medicines for patients with hyposmia (smell loss), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 18, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Priority Review to Genentech ’s Bispecific Antibody Glofitamab for People With Relapsed or Refractory Large B-Cell Lymphoma
South San Francisco, CA -- January 5, 2023 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 5, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Breakthrough Designation for Blood Test to Help Diagnose Inaccessible Brain Tumors
LONDON , Jan. 2, 2023. Datar Cancer Genetics Inc announced today that the US Food and Drug Administration (FDA) has granted ' Breakthrough Device Designation ' for its ' TriNetra-Glio ' , a blood test to help in the diagnosis of brain tumors. This is the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 2, 2023 Category: Pharmaceuticals Source Type: clinical trials

AbbVie Submits Supplemental New Drug Application to Support New Indication of Linzess for Functional Constipation in Children and Adolescents
NORTH CHICAGO, Ill., Dec. 16, 2022 . AbbVie today announced that it has submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS) to the U.S. Food and Drug Administration (FDA) for the treatment of children and adolescents 6 to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 16, 2022 Category: Pharmaceuticals Source Type: clinical trials

Breakthrough Therapy Designation Granted for Revumenib for the Treatment of Patients with Relapsed or Refractory KMT2A-Rearranged Acute Leukemia
WALTHAM, Mass., Dec. 6, 2022. Syndax Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 6, 2022 Category: Pharmaceuticals Source Type: clinical trials

Istesso Announces FDA Fast Track and Orphan Drug Designation for MBS2320
December 5, 2022 -- Istesso Limited, the immunometabolism drug discovery and development company, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Istesso’s investigational metabolic... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 5, 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 COVID-19 Vaccine in Children Under 5 Years
NEW YORK and MAINZ, GERMANY, DECEMBER 5, 2022— Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 5, 2022 Category: Pharmaceuticals Source Type: clinical trials

Symptom-driven inhaled corticosteroid/long-acting beta-agonist therapy for adult patients with asthma who are non-adherent to daily maintenance inhalers: a study protocol for a pragmatic randomized controlled trial
This study will (Part 1) complete a pragmatic randomized controlled trial to evaluate if an inhaler strategy that utilizes symptom-driven ICS inhalers is particularly beneficial in maintenance ICS inhaler non-adherent asthma patients, and (Part 2) use a dissemination and implementation (D&I) science conceptual framework to better understand patients ’ and providers’ views of inhaler nonadherence. This study, which will have an option of taking place entirely remotely, will use a Food and Drug Administration (FDA)-approved electronic sensor (Hailie® sensor) to monitor inhaler adherence and includes semi-structured ...
Source: Trials - December 5, 2022 Category: Research Source Type: clinical trials

FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region
November 30, 2022 -- The U.S. Food and Drug Administration today announced bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1., according to data... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 1, 2022 Category: Pharmaceuticals Source Type: clinical trials