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.

Emergent BioSolutions Announces FDA Acceptance of Biologics License Application for AV7909 Anthrax Vaccine Candidate
GAITHERSBURG, Md., June 24, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for AV7909 (Anthrax Vaccine... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 24, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
SILVER SPRING, Md., June 23, 2023. Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 23, 2023 Category: Pharmaceuticals Source Type: clinical trials

NIH and FDA Leaders Call for More Research, Lower Barriers to Improve and Implement Drug-Checking Tools Amid Overdose Epidemic
June 12, 2023 -- In a new Commentary in the New England Journal of Medicine, leaders at the National Institutes of Health and U.S. Food and Drug Administration highlight the urgent need to address current gaps in the research, development, and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 13, 2023 Category: Pharmaceuticals Source Type: clinical trials

Nirsevimab Unanimously Recommended by FDA Advisory Committee for the Prevention of RSV Lower Respiratory Tract Disease in Infants
8 June 2023 -- The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) has voted unanimously 21 to 0 that AstraZeneca and Sanofi’s nirsevimab has a favourable benefit risk profile for the prevention of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 8, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Announces Additional Steps to Modernize Clinical Trials
SILVER SPRING, Md., June 6, 2023. Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 6, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Advisory Committee Votes in Support of Approval for Pfizer ’s Vaccine Candidate to Help Prevent RSV in Infants Through Maternal Immunization
NEW YORK--(BUSINESS WIRE) May 18, 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 the available data support the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 18, 2023 Category: Pharmaceuticals Source Type: clinical trials

Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy to Treat Duchenne Muscular Dystrophy
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 12, 2023-- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) Cellular, Tissue and Gene... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 12, 2023 Category: Pharmaceuticals Source Type: clinical trials

Theravance Biopharma, Inc. Announces Orphan Drug Designation Granted to Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy
DUBLIN, May 9, 2023 /PRNewswire/ -- Theravance Biopharma, Inc. ( " Theravance Biopharma " or the " Company " ) (NASDAQ: TBPH) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) status to ampreloxetine... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 9, 2023 Category: Pharmaceuticals Source Type: clinical trials

Synlogic Receives Orphan Drug Designation from FDA for SYNB1934 for Treatment of Phenylketonuria
CAMBRIDGE, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 9, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena
April 6, 2023 -- Today, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. This drug was approved to reduce the risk of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 6, 2023 Category: Pharmaceuticals Source Type: clinical trials

Biosion Initiates Phase II Clinical Trial of BSI-045B in Atopic Dermatitis
NEWARK, Del. and NANJING, China, April 5, 2023. Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, today announced that it has successfully opened an IND following review by the U.S. Food and Drug Administration to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 5, 2023 Category: Pharmaceuticals Source Type: clinical trials

Biosion Initiates Phase II Clinical Trial of BSI-045B in Atopic Dermatitis
NEWARK, Del. and NANJING, China, April 4, 2023. Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, today announced that it has successfully opened an IND following review by the U.S. Food and Drug Administration to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 4, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval
SILVER SPRING, Md., March 24, 2023. Today, the U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 24, 2023 Category: Pharmaceuticals Source Type: clinical trials

Pfizer and BioNTech Receive 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 14, 2023 - Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to provide a single booster dose of the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 14, 2023 Category: Pharmaceuticals Source Type: clinical trials

US FDA Advisory Committee Votes to Support Effectiveness and Safety of GSK ’s Respiratory Syncytial Virus older Adult Vaccine Candidate
London, UK 01 March 2023 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the safety and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 1, 2023 Category: Pharmaceuticals Source Type: clinical trials