FDA

FDA approves olaparib/abiraterone combination for BRCA+ metastatic castration-resistant prostate cancer

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The FDA has approved olaparib (Lynparza) plus abiraterone and prednisone or prednisolone for the treatment of patients with deleterious or suspected BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an accompanying FDA-approved diagnostic test.1 The regulatory decision is supported by results from the Phase 3 PROpel study (NCT03732820) in which the olaparib regimen significantly improved … Read more

Ozempic Craze Spawned Inaccurate Black Market, FDA Warns

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The Food and Drug Administration warns people to stay away from suspicious sources of semaglutide, the active ingredient in popular weight-loss drugs Wegovy and Ozempic. The agency has received reports of adverse effects from people using compounding drug-made semaglutide. Also, some of these pharmacies produce different forms of semaglutide that have not been tested for … Read more

FDA Proposes New Easy-to-Read Drug Guide for Patients, Drug Information for Patients

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For immediate release: May 30, 2023 Statement from: Robert M. Califf, MD, MACC Food and Drug Commissioner – Food and Drug Administration Providing people with accurate and timely information to help them take their prescribed medications safely and effectively is a top priority for the United States Food and Drug Administration. Evidence suggests that easier-to-read … Read more

FDA Accepts NDA for DHE STS101 Nasal Powder Product for Acute Migraine

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The FDA accepted Satsuma Pharmaceuticals 505(b)(2) New Drug Application (NDA) for its investigational new dihydroergotamine (DHE) nasal powder product, STS101, for the acute treatment of migraine. The agency is expected to make a decision on the therapy by January 2024.1 “We are proud to announce the FDA acceptance for review of our NDA STS101, as … Read more

Pfizer’s Paxlovid is still free, for now, after the FDA granted full approval

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The Biden administration will continue to handle the distribution of free courses of Pfizer’s Paxlovid treatment for COVID-19 for at least another few months, the drugmaker said, even after the Food and Drug Administration on Thursday granted Pfizer full approval for it. market the pills. “At this time, the US government will continue to oversee … Read more

FDA approved spinal cord stimulators for chronic back pain

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On May 16, 2023, the US Food and Drug Administration (FDA) approved spinal cord stimulation (SCS) devices from the pharmaceutical company Abbott for the treatment of chronic back pain in people who have not had or are not eligible for receiving back surgery, per a press release from Abbott. The approval was granted after a … Read more

FDA approves Yuflyma as Adalimumab’s ninth biosimilar

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The US Food and Drug Administration (FDA) has approved the biosimilar adalimumab-aaty (Yuflyma) in a highly concentrated citrate-free formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States. Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing … Read more

Medical group challenges FDA action to limit use of COVID-19 drugs

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Case problem After the FDA issued an Emergency Use Authorization (EUA) for a COVID-19 drug but restricted its use to hospitalized patients, the Association of American Physicians and Surgeons (AAPS) launched a legal challenge. Has it prevailed? Credit: renaschild – stock.adobe.com Case facts From March 28 to June 15, 2020, the FDA issued an EUA … Read more

New nasal spray to reverse overdoses of fentanyl and other opioids gets FDA approval

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This photo provided by Indivior in May 2023 shows their drug Opvee. US health regulators have approved the drug to reverse overdoses caused by fentanyl and other strong opioids. Individual via AP hide caption toggle caption on/off Individual via AP This photo provided by Indivior in May 2023 shows their drug Opvee. US health regulators … Read more