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171 articles about FDA
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NeoImmuneTech Announces FDA Approval to Proceed with Second Study of NT-I7 (efineptakin alfa) in Adult COVID-19 Patients
7/27/2020
NIT’s second trial to evaluate NT-I7’s potential as a COVID-19 therapeutic
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LabCorp Receives Authorization for COVID-19 Sample Pooling
7/25/2020
New Method Aims to Improve Efficiency of COVID-19 Testing, Optimize Testing Supplies and Increase Overall Capacity
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Coronavirus (COVID-19) Update: Daily Roundup - July 24, 2020
7/24/2020
The U.S. Food and Drug Administration continued to take action in the ongoing response to the COVID-19 pandemic:.
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Coronavirus (COVID-19) Update: Daily Roundup - July 23, 2020
7/23/2020
The U.S. Food and Drug Administration continued to take action in the ongoing response to the COVID-19 pandemic:.
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FDA Lifts All Clinical Holds on Seladelpar
7/23/2020
Clinical hold lifted on seladelpar INDs in NASH, PBC and PSC Re-initiating clinical development focusing first on Phase 3 for PBC
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Coronavirus (COVID-19) Update: Daily Roundup - July 22, 2020
7/22/2020
The U.S. Food and Drug Administration continued to take action in the ongoing response to the COVID-19 pandemic:.
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MC2 Therapeutics Announces U.S. Food and Drug Administration Approval of Wynzora® Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) for Adults with Plaque Psoriasis
7/22/2020
MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced that the U.S. Food and Drug Administration has approved Wynzora® Cream for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.
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Coronavirus (COVID-19) Update: FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
7/2/2020
As part of continued action to protect the American public, the U.S. Food and Drug Administration is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol — a substance often used to create fuel and antifreeze that is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested.
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Coronavirus (COVID-19) Update: Daily Roundup - July 02, 2020
7/2/2020
The U.S. Food and Drug Administration continued to take action in the ongoing response to the COVID-19 pandemic:.
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EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome
7/2/2020
EUSA Pharma announced that the U.S. Food & Drug Administration has approved a randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated Acute Respiratory Distress Syndrome.
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Coronavirus (COVID-19) Update: Daily Roundup - July 01, 2020
7/1/2020
The U.S. Food and Drug Administration continued to take action in the ongoing response to the COVID-19 pandemic:.
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FDA In Brief: FDA Releases Final Report of Talc-containing Cosmetic Products Tested for Asbestos
3/9/2020
- The following quote is attributed to Susan Mayne , Ph.D., director of the Center for Food Safety and Applied Nutrition "The FDA is committed to keeping consumers safe from potentially contaminated cosmetic products. As part of this effort, in September 2018 , the agency awarded AMA Analytical Services, Inc. (AMA) a on
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FDA approves first generic of ProAir HFA
2/25/2020
Agency Supports Development of Complex Generic Drugs to Improve Competition and Access to More Affordable Medicines
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FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries
2/25/2020
The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health [25-February-2020] SILVER SPRING, Md. , Feb. 25, 2020 /PRNewswire/ -- Today, we are taking several important steps to make the use of laparoscopic power morcellators (LPMs) safer in gynecologic surgeries, including granting marketing authorization f
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FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications
2/20/2020
The following statement is attributed to Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health and Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. [20-February-2020] SILVER SPRING, Md. , Feb. 20, 2020 /PRNewswire/ -- Pharmacogenetic testing is a type of genetic test that in some instances can
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LSK BioPharma and Jiangsu Hengrui Medicine Announce FDA Clearance to Initiate a Phase 3 Clinical Trial in Advanced Hepatocellular Carcinoma (HCC)
4/9/2019
LSK BioPharma and Jiangsu Hengrui Medicine, Co., Ltd. announced that the Companies have received FDA clearance to initiate a clinical trial in the United States
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NorthStar Medical Radioisotopes, LLC Announces Business Update and Commercial Progress on RadioGenix® System Launch
2/5/2019
Positive RadioGenix System market momentum continues
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Tivic Health Receives FDA 510(k) Clearance To Market ClearUP™ To Treat Sinus Pain Associated With Allergic Rhinitis/Hay Fever
1/3/2019
Tivic Health Systems Inc. today announced that ClearUP Sinus Pain Relief, a first-in-class bioelectronic treatment for sinus pain due to allergic rhinitis (hay fever), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
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Aadi Bioscience Receives Breakthrough Therapy Designation for TARZIFYX™ (ABI-009) in PEComa Indication
1/3/2019
Lead Registration study in Advanced Malignant PEComa completes enrollment and company is On-Track for 2019 NDA Filing
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Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency's regulation of products containing cannabis and cannabis-derived compounds
12/20/2018
Today, the Agriculture Improvement Act of 2018 was signed into law.