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.

BioMarin Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Valoctocogene Roxaparvovec, Investigational Gene Therapy for Hemophilia A
SAN RAFAEL, Calif., March 8, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 8, 2021 Category: Pharmaceuticals Source Type: clinical trials

Further Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease
1 March 2021 -- AstraZeneca and FibroGen, Inc. (FibroGen) today announced that the US Food and Drug Administration (FDA) informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 1, 2021 Category: Pharmaceuticals Source Type: clinical trials

Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - First Single-Shot Vaccine in Fight Against Global Pandemic
NEW BRUNSWICK, N.J., February 27, 2021 – Johnson& Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 27, 2021 Category: Pharmaceuticals Source Type: clinical trials

Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
NEW BRUNSWICK, N.J., February 26, 2021 – Johnson& Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 26, 2021 Category: Pharmaceuticals Source Type: clinical trials

FDA Accepts for Priority Review Pfizer ’s Application for TicoVac™ (Tick-borne Encephalitis Vaccine)
February 23, 2021 - NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac™, its... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 23, 2021 Category: Pharmaceuticals Source Type: clinical trials

Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA
NEW YORK and MAINZ, GERMANY, February 19, 2021— Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 19, 2021 Category: Pharmaceuticals Source Type: clinical trials

Efanesoctocog Alfa Granted FDA Fast Track Designation for Treatment of Hemophilia A
February 18, 2021 -- The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for efanesoctocog alfa, previously known as BIVV001 (rFVIIIFc-VWF-XTEN), in patients with hemophilia A. Efanesoctocog alfa, a novel and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 18, 2021 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Sotorasib Priority Review Designation For The Treatment Of Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
THOUSAND OAKS, Calif., Feb. 16, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 16, 2021 Category: Pharmaceuticals Source Type: clinical trials

Lilly's Bamlanivimab (LY-CoV555) Administered with Etesevimab (LY-CoV016) Receives FDA Emergency Use Authorization for COVID-19
INDIANAPOLIS, Feb. 9, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 9, 2021 Category: Pharmaceuticals Source Type: clinical trials

Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., February 4, 2021 – Johnson& Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 4, 2021 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Fast Track Designation to Padeliporfin ImPACT for Steba Biotech
LUXEMBOURG, Jan. 17, 2021 /PRNewswire/ -- Steba biotech, pioneering developer of the IMmune Photo Activate Cancer Treatment (ImPACT), announced today that the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 17, 2021 Category: Pharmaceuticals Source Type: clinical trials

Lexicon Pharmaceuticals Provides Regulatory Update on Sotagliflozin in Heart Failure
The Woodlands, Texas, January 14, 2021 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it has received U.S. Food and Drug Administration (FDA) regulatory feedback that the results of its SOLOIST and SCORED Phase 3... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 14, 2021 Category: Pharmaceuticals Source Type: clinical trials

Novartis Ligelizumab (QGE031) Receives FDA Breakthrough Therapy Designation for Patients with Chronic Idiopathic Urticaria (CIU)
East Hanover, January 14, 2021 — Novartis today announced that the US Food and Drug Administration (FDA) has granted ligelizumab (QGE031) Breakthrough Therapy designation for the treatment of chronic idiopathic urticaria (CIU), also known... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 14, 2021 Category: Pharmaceuticals Source Type: clinical trials

U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck ’s Investigational 15-valent Pneumococcal Conjugate Vaccine, for Use in Adults 18 Years of Age and Older
KENILWORTH, N.J.--(BUSINESS WIRE) January 12, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 12, 2021 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Orphan Drug Designation for PVSRIPO for the Treatment of Advanced Melanoma
DURHAM, NC, January 10, 2021– Istari Oncology, Inc., a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for PVSRIPO for the treatment of advanced... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 10, 2021 Category: Pharmaceuticals Source Type: clinical trials