TUESDAY, Nov. 27, 2018 — A major update of the United States’ system for approving medical devices was announced yesterday
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‘Breakthrough’ treatment for peanut allergy awaits FDA check
Information provided last year by specialists from the American College of Allergy, Asthma, and Immunology (ACAAI) indicates that almost 2.5
Continue reading »Poll: Is the FDA Pre-Cert program an effective way to regulate digital health products?
Since new FDA Commissioner Scott Gottlieb announced the FDA precertification program, the agency has been moving full speed ahead to
Continue reading »FDA Approves Pifeltro
KENILWORTH, N.J.–(BUSINESS WIRE) August 30, 2018 –Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced
Continue reading »New Blood Pressure Medication Recall Due To ‘Life Threatening’ Mixup
The FDA issued a new blood pressure medication recall due to a potentially life-threatening labeling mixup. According to a report
Continue reading »FDA Approves First Generic EpiPen
FRIDAY, Aug. 17, 2018 — The first generic version of the EpiPen has been approved by the U.S. Food and
Continue reading »Ivosidenib earns FDA approval against IDH1+ acute myeloid leukemia
Clinical trials at University of Colorado Cancer Center and elsewhere now result in the drug ivosidenib earning approval from the
Continue reading »Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD)
DUBLIN, July 23, 2018 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food
Continue reading »FDA grants first approval for CA drug under new pilot programs
(HealthDay)—The U.S. Food and Drug Administration has approved ribociclib (Kisqali) in combination with an aromatase inhibitor (AI) as an initial
Continue reading »FDA approves tibsovo for acute myeloid leukemia
(HealthDay)—Tibsovo (ivosidenib) tablets have been approved by the U.S. Food and Drug Administration to treat relapsed or refractory acute myeloid
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