Food and Drug Administration (FDA)
5600 Fishers Lane
Rockville
Maryland
20857
United States
Tel: 888-463-6332 or 1-888-INFO-FDA (1-888-463-6332)
Website: http://www.fda.gov/
About Food and Drug Administration (FDA)
FDA Overview:
The Food and Drug Administration is one of the nation's oldest and most respected consumer protection agencies. This presentation will tell you about FDA's responsibilities, the tools we use to fulfill those responsibilities, and our priorities for improving the way we serve the public.
•Stated most simply, FDA's mission is:
- to promote and protect the public health by helping safe and effective products reach the market in a timely way,
- To monitor products for continued safety after they are in use, and
- To help the public get the accurate, science-based information needed to improve health.
FDA's Mission Statement
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
22338 articles with Food and Drug Administration (FDA)
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Lupus Research Alliance Hails Approval of Aurinia's Lupkynis(TM) (voclosporin)
1/23/2021
First Oral Treatment for Lupus Nephritis; Second Lupus Treatment to Receive FDA Approval in Past Month
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FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis
1/23/2021
- LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death - - LUPKYNIS demonstrated significantly improved renal response rates compared to typical standard-of-care (SoC) in clinical trials
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U.S. Food and Drug Administration Approves OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma
1/22/2021
U.S. Food and Drug Administration Approves OPDIVO ® (nivolumab) in Combination with CABOMETYX ® (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma
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Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
1/22/2021
Exelixis Announces U.S. FDA Approval of CABOMETYX ® (cabozantinib) in Combination with OPDIVO ® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
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Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV
1/22/2021
CABENUVA offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression
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Boston Scientific Receives FDA Approval For The Vercise Genus™ Deep Brain Stimulation System
1/22/2021
Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval of its fourth-generation Vercise Genus™ Deep Brain Stimulation (DBS) System.
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The drug, a combination of cabotegravir and rilpivirine, is a complete therapy for HIV-1 infection in adults who are virologically suppressed.
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ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment
1/21/2021
Cabenuva allows virologically suppressed adults living with HIV without prior treatment failure or resistance to cabotegravir or rilpivirine to maintain viral suppression with 12 dosing days per year
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FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV
1/21/2021
The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiret
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FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone) for Unclassifiable Interstitial Lung Disease
1/21/2021
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has accepted the company’s supplemental New Drug Application and granted Priority Review for Esbriet® for the treatment of unclassifiable interstitial lung disease.
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OraSure’s Oragene®•Dx Saliva Collection Kit Included in Industry’s First FDA Authorization for a Whole Exome Sequencing Platform
1/21/2021
OraSure Technologies, Inc., a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, announced that its Oragene®•Dx saliva collection device was included as a component in the De Novo authorization granted by the U.S. Food & Drug Administration to Helix for their Helix® Laboratory Platform1, a whole exome sequencing platform.
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The U.S. FDA has accepted Genentech’s supplemental New Drug Application and has granted Priority Review for the company’s unclassifiable interstitial lung disease (UILD) treatment Esbriet® (pirfenidone).
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The U.S. Food and Drug Administration approved Merck and Bayer’s heart failure drug vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, the pharma giants announced this morning.
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Occlutech's Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation for Heart Failure (HF)
1/19/2021
Occlutech, a privately-held company, announced that the U.S Food and Drug Administration has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator for heart failure patients with preserved or reduced ejection fraction.
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Molecular Templates Announces FDA Acceptance of IND Application for MT-6402, a PD-L1-Targeted Engineered Toxin Body Enabled with Proprietary Antigen Seeding Technology
1/19/2021
Dosing in Phase 1 Study in Subjects with PD-L1-Positive Cancers Expected to Start in 2Q21
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FDA Grants Rare Pediatric Disease, Orphan Drug Designation to Taysha’s Rare Epilepsy Candidate
1/19/2021
The U.S. FDA has granted rare pediatric disease and orphan drug designations for Taysha Gene Therapies’ AAV9-based gene treatment candidate currently in development for epilepsy caused by SLC13A5 deficiency. -
ADDING MULTIMEDIA — ENHERTU® Approved in the U.S. for the Treatment of Patients with Previously Treated HER2 Positive Advanced Gastric Cancer
1/18/2021
Daiichi Sankyo Company, Limited and AstraZeneca’s ENHERTU® has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
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The U.S. Food and Drug Administration approved Janssen Pharmaceuticals’ Darzalex Faspro for adults with newly diagnosed light chain amyloidosis.
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After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up. Here’s a look.
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Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO® (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) Amyloidosis
1/15/2021
- DARZALEX FASPRO® Utilizing ENHANZE® Represents First and Only Approved Treatment for Patients with Newly Diagnosed AL Amyloidosis - - Accelerated Approval of DARZALEX FASPRO®-based Combination Regimen Supported by the PHASE 3 ANDROMEDA Study Demonstrating a Significantly Higher Hematologic Complete Response Rate in this Rare and Serious Blood Cell Disorder -