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.

FDA Approves First COVID-19 Treatment for Young Children
SILVER SPRING, Md., April 25, 2022.Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 25, 2022 Category: Pharmaceuticals Source Type: clinical trials

Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM
PARSIPPANY, N.J., TEL AVIV& PARIS– April 19, 2022 - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced that the U.S. Food and Drug Administration... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 19, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
SILVER SPRING, Md., April 15, 2022 , Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 15, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials
SILVER SPRING, Md., April 13, 2022 -- Today, the U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 13, 2022 Category: Pharmaceuticals Source Type: clinical trials

Henlius' Serplulimab Granted Orphan-Drug Designation in the United States for Small Cell Lung Cancer
SHANGHAI, April 7, 2022 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the United States Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG (serplulimab) for the treatment of small... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 7, 2022 Category: Pharmaceuticals Source Type: clinical trials

Iovance Biotherapeutics Announces Regulatory and Clinical Updates for Lifileucel In Melanoma
SAN CARLOS, Calif., April 05, 2022 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that the U.S. Food and Drug Administration... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 5, 2022 Category: Pharmaceuticals Source Type: clinical trials

US Food and Drug Administration Revises Emergency Use Authorization for Sotrovimab due to Omicron BA.2 Subvariant
London UK - 25 March 2022 -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the US Food and Drug Administration has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab, an... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 25, 2022 Category: Pharmaceuticals Source Type: clinical trials

Moderna Submits Amendment to the Emergency Use Authorization for an Additional Booster Dose of its COVID-19 Vaccine in the U.S.
CAMBRIDGE, MA / ACCESSWIRE / March 17, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a request to the U.S. Food and Drug Administration... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 17, 2022 Category: Pharmaceuticals Source Type: clinical trials

Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults
NEW YORK and MAINZ, GERMANY, MARCH 15, 2022— Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 15, 2022 Category: Pharmaceuticals Source Type: clinical trials

Corium Receives FDA Approval of ADLARITY (donepezil transdermal system) for Treatment of Patients with Alzheimer's Disease
BOSTON, March 14, 2022. Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 14, 2022 Category: Pharmaceuticals Source Type: clinical trials

AbbVie Seeks New Indication for IMBRUVICA (ibrutinib) in Pediatric Patients with Chronic Graft Versus Host Disease (cGVHD)
NORTH CHICAGO, Ill., Feb. 28, 2022. AbbVie today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA (ibrutinib) for the treatment of pediatric and adolescent... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 28, 2022 Category: Pharmaceuticals Source Type: clinical trials

Update on FDA Adjustment to Evusheld Dosage Regimen in US
25 February 2022 -- The US Food and Drug Administration (FDA) has amended the Emergency Use Authorisation (EUA) Fact Sheet for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) for pre-exposure prophylaxis (prevention) of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 25, 2022 Category: Pharmaceuticals Source Type: clinical trials

AbbVie Submits Supplemental New Drug Application to U.S. FDA for cariprazine (VRAYLAR) for the Adjunctive Treatment of Major Depressive Disorder
NORTH CHICAGO, Ill., Feb. 22, 2022. AbbVie today announced that it has submitted a supplemental New Drug Application (sNDA) for cariprazine (VRAYLAR) to the U.S. Food and Drug Administration (FDA) for the adjunctive treatment of major depressive... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 22, 2022 Category: Pharmaceuticals Source Type: clinical trials

Efficacy and safety of Tengfu Jiangya tablet combined with valsartan/amlodipine in the treatment of stage 2 hypertension: study protocol for a randomized controlled trial
DiscussionThis is the first placebo-controlled randomized trial conducted to evaluate the efficacy and safety of a Chinese herbal extract combined with Val/Aml in patients with stage 2 hypertension. Our study may help to provide evidence-based recommendations of a complementary preventive measure for stage 2 hypertension.Trial registrationChinese Clinical Trial RegistryChiCTR2000030611. Registered on 8 March 2020 (Source: Trials)
Source: Trials - February 22, 2022 Category: Research Source Type: clinical trials

Pfizer and BioNTech Provide Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age
NEW YORK& MAINZ, Germany--(BUSINESS WIRE) February 11, 2022 -- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced plans to extend their rolling submission to the U.S. Food and Drug Administration (FDA) seeking to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 11, 2022 Category: Pharmaceuticals Source Type: clinical trials