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.

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Talquetamab for the Treatment of Relapsed or Refractory Multiple Myeloma
June 29, 2022 (RARITAN, N.J.)– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for talquetamab for the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 29, 2022 Category: Pharmaceuticals Source Type: clinical trials

Astellas Announces FDA Update on the FORTIS Clinical Trial of AT845 in Adults with Late-Onset Pompe Disease
TOKYO, June 26, 2022. Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) announced that the US Food and Drug Administration (FDA) has placed a clinical hold on the FORTIS Phase 1/2 trial following the occurrence... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 27, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Fast Track Designation for BioCryst ’s ALK-2 Inhibitor, BCX9250
RESEARCH TRIANGLE PARK, N.C., June 08, 2022 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BCX9250 for the prevention of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 8, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older
Novavax COVID-19 vaccine receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee If Emergency Use Authorization is granted by the FDA, the Novavax COVID-19 vaccine would become... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 7, 2022 Category: Pharmaceuticals Source Type: clinical trials

Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone
This article explored the decisions taken by the Pharmacy Board of Sierra Leone through its Expert Committee on Medicine Safety and Clinical Trials regarding clinical trials oversight during the Ebola epidemic and the lessons learned. This independent expert committee assessed and provided scientific opinions to the Pharmacy Board of Sierra Leone to inform approval of all clinical trials within 10 –15 working days. We also requested for assisted review from the African Vaccine Regulatory Forum and support from the US Food and Drug Administration through a unilateral recognition and reliance memorandum of understanding. I...
Source: Trials - June 6, 2022 Category: Research Source Type: clinical trials

FDA Grants Efanesoctocog Alfa Breakthrough Therapy Designation for Hemophilia A
Paris and Stockholm– June 1, 2022– The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for the treatment of people with hemophilia A, a rare and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 1, 2022 Category: Pharmaceuticals Source Type: clinical trials

Pfizer Granted FDA Fast Track Designation for Ervogastat/Clesacostat Combination for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
NEW YORK--(BUSINESS WIRE) May 26, 2022 -- Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Pfizer’s investigational combination therapy for the treatment of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 26, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV
FOSTER CITY, Calif.--(BUSINESS WIRE)--May 16, 2022-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 16, 2022 Category: Pharmaceuticals Source Type: clinical trials

Johnson & Johnson Updates U.S. COVID-19 Vaccine Fact Sheet
NEW BRUNSWICK, NJ, May 5, 2022 - Our number one priority is the safety and well-being of those who use the Johnson& Johnson COVID-19 vaccine. Johnson& Johnson, in close coordination with the U.S. Food and Drug Administration (FDA), has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 5, 2022 Category: Pharmaceuticals Source Type: clinical trials

Sapience Therapeutics Receives FDA Orphan Drug Designation for ST101 for the Treatment of Advanced Melanoma
HARRISON, N.Y., May 3, 2022. Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, announced today that the U.S. Food and Drug Administration... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 3, 2022 Category: Pharmaceuticals Source Type: clinical trials

Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age
NEW YORK and MAINZ, GERMANY, APRIL 26, 2022— 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 10-µg... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 26, 2022 Category: Pharmaceuticals Source Type: clinical trials