Novartis C.E.O. Defends Company’s Decision to Withhold False Data From the F.D.A.

The chief executive of Novartis on Wednesday defended the company’s decision to delay telling the Food and Drug Administration about manipulated data involving its $2.1 million gene therapy treatment, saying that it “thoroughly, aggressively” investigated the issue and that patient safety was never threatened. Vas Narasimhan, the chief executive, also indicated in a call with investors that the company was […]

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National Cancer Chief Named as Acting Head of the F.D.A.

WASHINGTON, D.C. — Dr. Norman E. “Ned” Sharpless, director of the National Cancer Institute, will serve as acting commissioner of the Food and Drug Administration, Alex M. Azar III, secretary of health and human services, announced on Tuesday. Dr. Sharpless temporarily will fill the post being vacated by Dr. Scott Gottlieb, who stunned public health experts, lawmakers and consumer groups […]

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F.D.A. Commissioner Scott Gottlieb Resigns

WASHINGTON — Scott Gottlieb, the commissioner of the Food and Drug Administration, known for his aggressive efforts to regulate the tobacco and e-cigarette industries, resigned Tuesday. Dr. Gottlieb, whose wife and three children have remained in their Westport, Conn., home since he took office, said he was weary of the commute and missed his family. Dr. Gottlieb had been subject […]

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FDA Approves Adhansia XR

STAMFORD, Conn.–(BUSINESS WIRE) March 01, 2019 –Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII, a central nervous system (CNS) stimulant, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older. In a simulated Adult Workplace Environment (AWE) study, Adhansia […]

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FDA Approves Esperoct

Bagsværd, Denmark, 19 February 2019 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for Esperoct for the treatment of adults and children with hemophilia A. Esperoct is the brand name for turoctocog alfa pegol, N8-GP. Esperoct is indicated for use in adults and children with hemophilia A (congenital factor […]

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FDA Approves First Generic Version of Advair for Asthma, COPD

THURSDAY, Jan. 31, 2019 — The first generic form of the Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler has been approved by the U.S. Food and Drug Administration. The medication can now be used to treat children aged 4 years and older with asthma and adults with asthma or chronic obstructive pulmonary disease (COPD). The generic inhaler is […]

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FDA investigating paclitaxel-coated balloons, paclitaxel-eluting stents

(HealthDay)—The U.S. Food and Drug Administration alerted health care providers on Thursday that the agency is investigating the use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease (PAD) in the femoropopliteal artery because of a potentially increased mortality risk in the long term. In a letter to peripheral interventionalists and vascular medicine physicians, the FDA referenced data […]

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Teething jewelry linked to at least one baby’s death: FDA

(HealthDay)—Teething jewelry products, such as necklaces, pose significant safety risks and have been tied to at least one baby’s death, the U.S. Food and Drug Administration warns. Potential threats include choking, strangulation, injury to the mouth and infection. These products should not be used to relieve teething pain in infants, the agency said. The products also shouldn’t be used to […]

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