News & Events

FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

Mon, 2018-12-10 14:23
FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

Mon, 2018-12-10 09:26
FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics

Thu, 2018-12-06 09:58
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products

Thu, 2018-12-06 08:32
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of vitro companion diagnostics for classes of oncology therapeutic products

FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

Tue, 2018-12-04 10:12
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

Fri, 2018-11-30 14:51
FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

Thu, 2018-11-29 08:27
FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

Wed, 2018-11-28 17:10
FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

Wed, 2018-11-28 14:38
The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

Wed, 2018-11-28 12:10
The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway

Tue, 2018-11-27 14:58
FDA Commissioner statement on modernizing the 510(k) pathway by creating policies that rely on newer predicates with modern characteristics related to their safety and performance

Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

Tue, 2018-11-27 10:02
FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption

FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

Tue, 2018-11-27 08:31
FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health

Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce <i>E. coli</i> O157:H7 outbreak investigation

Mon, 2018-11-26 17:41
Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

Mon, 2018-11-26 16:28
The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness...

Mon, 2018-11-26 05:58
FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls.

FDA approves new treatment for patients with acute myeloid leukemia

Wed, 2018-11-21 11:57
The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder

Tue, 2018-11-20 14:36
FDA issued warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine.

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety

Tue, 2018-11-20 10:30
FDA provides updates on medical device safety action plan describing recent actions we’ve taken to enhance device safety including implementation of NEST and registries on women’s health.

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

Tue, 2018-11-20 08:32
The FDA approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

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