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Press releases from FDA
Updated: 3 hours 40 min ago

FDA approves first cancer treatment for any solid tumor with a specific genetic feature

Tue, 05/23/2017 - 14:01
The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated
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FDA approves first drug to specifically treat giant cell arteritis

Mon, 05/22/2017 - 09:50
The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis.
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FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis

Wed, 05/17/2017 - 15:14
The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33. The agency based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from earlier human clinical trials. The approach provides a pathway for adding additional, rare mutations of the disease, based on laboratory data.
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FDA warns Americans about risk of inaccurate results from certain lead tests

Wed, 05/17/2017 - 07:51
The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States.
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FDA authorizes use of new device to treat esophageal birth defect in babies

Fri, 05/12/2017 - 11:51
The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia.
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FDA approves drug to treat ALS

Fri, 05/05/2017 - 15:59
The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.
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FDA takes action against Florida medicated animal feed manufacturer

Fri, 05/05/2017 - 13:48
On May 4, 2017, the United States District Court for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Syfrett Feed Company Inc. of Okeechobee, Florida; its owner and President Charles B. Syfrett I; Vice President Melissa S. Montes De Oca; and Operations Manager Charles B. Syfrett II. The consent decree requires the company to adequately control its production of medicated animal feeds and to comply with federal law before it can resume its medicated feed operations.
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FDA approves new combination treatment for acute myeloid leukemia

Fri, 04/28/2017 - 09:20
The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML.
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FDA approves first treatment for a form of Batten disease

Thu, 04/27/2017 - 12:02
The U.S. Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency.
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FDA expands approved use of Stivarga to treat liver cancer

Thu, 04/27/2017 - 11:45
The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer in almost a decade.
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FDA takes action against 14 companies for selling illegal cancer treatments

Tue, 04/25/2017 - 09:07
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.
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FDA statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research, on new warnings about the use of codeine and tramadol in children & nursing mothers

Thu, 04/20/2017 - 10:42
The health and safety of children is a top priority at the FDA, which is why today we are requiring a series of changes to the labeling of two types of opioid medications in order to help better protect children from serious risks associated with these medicines – codeine (found in some prescription pain and cough medicines and some over-the-counter cough medicines) and tramadol (found in some prescription pain medicines).
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FDA allows marketing of first whole slide imaging system for digital pathology

Wed, 04/12/2017 - 15:56
The U.S. Food and Drug Administration today permitted marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. This is the first time the FDA has permitted the marketing of a WSI system for these purposes.
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FDA approves first drug to treat tardive dyskinesia

Tue, 04/11/2017 - 16:35
The U.S. Food and Drug Administration today approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition.
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FDA approves two hepatitis C drugs for pediatric patients

Fri, 04/07/2017 - 09:27
The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults.
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FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions

Thu, 04/06/2017 - 10:18
The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.
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FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

Fri, 03/31/2017 - 17:34
The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.
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FDA approves new drug to treat multiple sclerosis

Wed, 03/29/2017 - 07:44
On March 28, the U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional.
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FDA approves new eczema drug Dupixent

Tue, 03/28/2017 - 10:14
The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
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FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

Mon, 03/27/2017 - 15:04
The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.
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