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.

Lilly's Bebtelovimab Receives Emergency Use Authorization for the Treatment of Mild-to-Moderate COVID-19
INDIANAPOLIS, Feb. 11, 2022 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant, Eli Lilly and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 11, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Awards QIDP Designation for Prevention of Chlamydia to Evofem Biosciences
SAN DIEGO, Feb. 9, 2022. Evofem Biosciences, Inc., announced today that the U.S. Food and Drug Administration (FDA) has awarded " Qualified Infectious Disease Product " (QIDP) Designation to EVO100 (the investigational name for Phexxi (lactic acid,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 9, 2022 Category: Pharmaceuticals Source Type: clinical trials

Syros Receives FDA Orphan Drug Designation for Tamibarotene for the Treatment of MDS
CAMBRIDGE, Mass.--(BUSINESS WIRE) February 2, 2022 -- Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced that the U.S. Food and Drug Administration (FDA) has granted... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 2, 2022 Category: Pharmaceuticals Source Type: clinical trials

Mix-and-Match Trial Finds Additional Dose of COVID-19 Vaccine Safe, Immunogenic
January 26, 2022 -- In adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization (EUA) or approved by the U.S. Food and Drug Administration, an additional booster dose of any of these... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 26, 2022 Category: Pharmaceuticals Source Type: clinical trials

Gilead Announces Partial Clinical Hold for Studies Evaluating Magrolimab in Combination With Azacitidine
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 25, 2022-- Gilead Sciences Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 25, 2022 Category: Pharmaceuticals Source Type: clinical trials

Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
January 24, 2022 -- As we have throughout the COVID-19 pandemic, the U.S. Food and Drug Administration has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind.... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 24, 2022 Category: Pharmaceuticals Source Type: clinical trials

Merck Provides U.S. and Japan Regulatory Update for Gefapixant
KENILWORTH, N.J.--(BUSINESS WIRE) January 24, 2022 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 24, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Accepts for Review Libtayo (cemiplimab-rwlc) in Combination with Chemotherapy for First-line Treatment of Advanced NSCLC
TARRYTOWN, N.Y., Jan. 19, 2022. Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 19, 2022 Category: Pharmaceuticals Source Type: clinical trials

Ascletis Announces U.S. IND Approval of ASC22 (Envafolimab), a Subcutaneously Administered PD-L1 Antibody for Functional Cure of Chronic Hepatitis B
HANGZHOU and SHAOXING, China, Jan. 17, 2022. Ascletis Pharma Inc. announced today the Investigational New Drug (IND) application approval by U.S. Food and Drug Administration (FDA) and initiation of global development of ASC22 (Envafolimab), a... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 17, 2022 Category: Pharmaceuticals Source Type: clinical trials

AbbVie Announces U.S. FDA Granted Breakthrough Therapy Designation (BTD) to Telisotuzumab Vedotin (Teliso-V) for Previously Treated Non-Small Cell Lung Cancer
NORTH CHICAGO, Ill., Jan. 4, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 4, 2022 Category: Pharmaceuticals Source Type: clinical trials

Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
RARITAN, N.J., Dec. 29, 2021. The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of teclistamab for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 29, 2021 Category: Pharmaceuticals Source Type: clinical trials

Merck and Ridgeback ’s Molnupiravir Receives U.S. FDA Emergency Use Authorization for the Treatment of High-Risk Adults With Mild to Moderate COVID-19
KENILWORTH, N.J.& MIAMI--(BUSINESS WIRE) December 23, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 23, 2021 Category: Pharmaceuticals Source Type: clinical trials

Patritumab Deruxtecan Granted U.S. FDA Breakthrough Therapy Designation in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
TOKYO, MUNICH& BASKING RIDGE, N.J.--(BUSINESS WIRE) December 23, 2021 --Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 23, 2021 Category: Pharmaceuticals Source Type: clinical trials

MindMed Provides Status Update on IND for Phase 2b Trial of LSD for the Treatment of Generalized Anxiety Disorder
NEW YORK, Dec. 21, 2021. Mind Medicine (MindMed) Inc. (the " Company " ), a leading biotech company developing psychedelic-inspired therapies, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its IND... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 21, 2021 Category: Pharmaceuticals Source Type: clinical trials

Gilead Announces Clinical Hold on Studies Evaluating Injectable Lenacapavir for HIV Treatment and Prevention Due to Vial Quality Concerns
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 21, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 21, 2021 Category: Pharmaceuticals Source Type: clinical trials