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 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
Tres Hermanos Bakery of Wyoming, MI is recalling its white Telera and Bolillo Mexican salt breads because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!
FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus
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 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.
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.
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.
Kwik Trip, Inc. located in La Crosse, WI is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of cashews or almonds Read The Complete Story!
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
Sunshine Mills, Inc. is issuing a voluntary recall of select products of Evolve Puppy, Sportsman’s Pride Large Breed Puppy and Triumph Chicken and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D. Read The Complete Story!
FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption
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 E. coli O157:H7 outbreak investigation
The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).
FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls.
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 […]
FDA issued warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine.