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FDA Extends Trikafta Approval to Even Younger Cystic Fibrosis Patients

The FDA expanded the indication for elexacaftor, tezacaftor, and ivacaftor (Trikafta) in cystic fibrosis to include even younger children, maker Vertex Pharmaceuticals announced. The three-drug combination’s expanded label now covers children ages 2 to 5 years who have cystic fibrosis and either a F508del mutation in the CFTR gene or a CFTR gene mutation that […]

Experts Break Down What Could Help Improve Access to Paxlovid

Access to Paxlovid, the first oral antiviral treatment for COVID-19, has expanded since the FDA issued an emergency use authorization (EUA) for the Pfizer-made medication in December. However, physicians and pharmacists say there is still more that can be done to make sure the potentially life-saving drug reaches the right people at the right time. […]

Medtronic Expands Recall to Include More Than 463,000 Insulin Pumps

Latest Diabetes News TUESDAY, Oct. 5, 2021 (HealthDay News) Medtronic has expanded a recall of its MiniMed 600 series insulin pumps to include more than 463,000 of the devices. The pumps may deliver incorrect dosing of insulin and the recall has been identified by the U.S. Food and Drug Administration as a Class […]

Frozen Shrimp Recall Due to Salmonella Contamination – MedicineNet Health News

Latest Infectious Disease News TUESDAY, Aug. 17, 2021 Avanti Frozen Foods has expanded its recall of various frozen cooked, peeled and deveined shrimp products that may be contaminated with salmonella. The more than two dozen products were sold under various brand names and distributed across the United States between November 2020 and May […]

Monoclonal Antibody Cocktail Authorized for Post-COVID Exposure

FDA expanded the emergency use authorization (EUA) for the monoclonal antibody cocktail casirivimab and imdevimab, to include post-exposure prophylaxis (PEP) among certain people exposed to COVID-19, manufacturer Regeneron announced on Friday. Casirivimab-imdevimab (REGEN-COV) is the first monoclonal antibody treatment that can be used either as a treatment for COVID-19 or after exposure but prior to […]

Shingrix OK’d For Immunocompromised Adults

FDA expanded the approval of Shingrix, an adjuvanted recombinant zoster vaccine, for adults at increased risk of shingles due to immunosuppression, manufacturer GlaxoSmithKline (GSK) announced on Monday. The expanded indication is for adults ages 18 and older at a greater risk of shingles due to “immunodeficiency or immunosuppression caused by known disease or therapy.” The […]

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