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.

Senhwa's Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Medulloblastoma
TAIPEI and SAN DIEGO, Dec. 17, 2021. Senhwa Biosciences, Inc., a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that the US Food and Drug Administration (FDA) has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 17, 2021 Category: Pharmaceuticals Source Type: clinical trials

U.S. FDA Grants Priority Review for Spesolimab for the Treatment of Flares in Patients with Generalized Pustular Psoriasis (GPP)
Ridgefield, Conn., December 15, 2021– Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for spesolimab for the treatment of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 15, 2021 Category: Pharmaceuticals Source Type: clinical trials

Merck Announces Clinical Holds on Studies Evaluating Islatravir for the Treatment and Prevention of HIV-1 Infection
KENILWORTH, N.J.--(BUSINESS WIRE) December 13, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has placed clinical holds on the investigational new drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 13, 2021 Category: Pharmaceuticals Source Type: clinical trials

Lilly's Bamlanivimab with Etesevimab Authorized as the First and Only Neutralizing Antibody Therapy for Emergency Use in COVID-19 Patients Under the Age of 12
INDIANAPOLIS, Dec. 3, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 3, 2021 Category: Pharmaceuticals Source Type: clinical trials

Travere Therapeutics Announces Successful Outcome from Type A Meeting with U.S. FDA for Sparsentan in Focal Segmental Glomerulosclerosis
SAN DIEGO, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced a successful outcome from the Company’s Type A meeting with the U.S. Food and Drug Administration (FDA) in... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 7, 2021 Category: Pharmaceuticals Source Type: clinical trials

Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2
AbstractA recently published article described the safety, tolerability, and pharmacokinetic profile of molnupiravir (Painter et al. 2021), a novel antiviral agent with potent activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19). Here, we report an unprecedented collaboration between sponsor, contract research organization (CRO), and regulatory authorities that enabled accelerated generation of these phase I data, including administration of the first-in-human (FIH) dose of molnupiravir within 5 days of receiving regulatory approval in ...
Source: Trials - August 23, 2021 Category: Research Source Type: clinical trials

Moderna Announces FDA Authorization of Third Dose of COVID-19 Vaccine for Immunocompromised Individuals
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 13, 2021-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 13, 2021 Category: Pharmaceuticals Source Type: clinical trials

VTX-801 Receives U.S. FDA Fast Track Designation for the Treatment of Wilson Disease
Paris, France and New York, NY, August 12, 2021– Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 12, 2021 Category: Pharmaceuticals Source Type: clinical trials

Moderna Receives FDA Fast Track Designation for Respiratory Syncytial Virus (RSV) Vaccine (mRNA-1345)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 3, 2021-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 3, 2021 Category: Pharmaceuticals Source Type: clinical trials

FDA Expands Authorized Use of REGEN-COV (casirivimab and imdevimab)
TARRYTOWN, N.Y., July 30, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 30, 2021 Category: Pharmaceuticals Source Type: clinical trials

FDA Broadens Existing Emergency Use of Lilly and Incyte's Baricitinib in Patients Hospitalized with COVID-19 Requiring Oxygen
INDIANAPOLIS, July 29, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today the U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 29, 2021 Category: Pharmaceuticals Source Type: clinical trials

Incyte Provides Regulatory Update on Retifanlimab for the Treatment of Certain Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
WILMINGTON, Del.--(BUSINESS WIRE) July 23, 2021 -- Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 23, 2021 Category: Pharmaceuticals Source Type: clinical trials

Lilly's Donanemab receives U.S. FDA's Breakthrough Therapy Designation for Treatment of Alzheimer's disease
INDIANAPOLIS, June 24, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company ' s (NYSE: LLY) investigational antibody therapy for Alzheimer ' s... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 24, 2021 Category: Pharmaceuticals Source Type: clinical trials

Genentech ’s Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children
South San Francisco, CA -- June 24, 2021 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 24, 2021 Category: Pharmaceuticals Source Type: clinical trials

Resolve Therapeutics Receives FDA Approval to Initiate Phase 2 Clinical Trial of RSLV-132 in Long Covid Patients
ST. PETERSBURG, Fla., June 23, 2021 /PRNewswire/ -- Resolve Therapeutics, pioneering first-in-class, targeted, safe therapies for underserved autoimmune diseases, today announced that the US Food and Drug Administration has approved a... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 23, 2021 Category: Pharmaceuticals Source Type: clinical trials