Health News

FDA Approves Sarclisa (isatuximab-irfc) in Combination with Carfilzomib and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

PARIS, March 31, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. “In the Phase 3 IKEMA study, the addition […]

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FDA Approves Abecma

FDA Approves Abecma (idecabtagene vicleucel) as the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE) March 26, 2021 — Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has approved Abecma (idecabtagene vicleucel; […]

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FDA Approves Fotivda

FDA Approves Fotivda (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma BOSTON–(BUSINESS WIRE) March 10, 2021 — AVEO Oncology (Nasdaq: AVEO) today announced that the U.S. Food and Drug Administration (FDA) has approved Fotivda (tivozanib) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma […]

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Pfizer’s Newest Vaccine Plant Has Mold Issues, History of Recalls

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Pfizer’s management knew last year there was “a mold issue” at the Kansas facility now slated to produce the drugmaker’s urgently needed covid-19 vaccine, according to a Food and Drug Administration inspection report. The McPherson, Kansas, facility, which FDA inspectors wrote […]

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Biden’s Criticism of Trump Team’s Vaccine Contracts Is a Stretch

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. During a March 2 news conference on the covid-19 pandemic, President Joe Biden claimed that former President Donald Trump’s administration did not ensure there would be enough vaccines for the American public. “When I came into office, the prior administration had […]

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Adalimumab Earns FDA Approval for Ulcerative Colitis in Children

Adalimumab has received approval from the Food and Drug Administration for use in pediatric patients aged 5 years and older with moderately to severely active ulcerative colitis (UC), according to a press release from manufacturer AbbVie. Approval was based on data from the phase 3 ENVISION 1 randomized, double-blind study (NCT02065557) in which 60% of patients receiving the higher […]

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FDA Grants Emergency Use to Johnson & Johnson COVID-19 Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. And then there were three. The US Food and Drug Administration (FDA) today granted emergency use authorization (EUA) to the Ad26.COV2.S vaccine from Janssen/Johnson & Johnson (J&J) for people 18 and older after reviewing its safety and efficacy data. More vaccine […]

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U.S. FDA advisory panel votes in favor of Johnson & Johnson's COVID-19 vaccine

FILE PHOTO: Vials labelled “COVID-19 Coronavirus Vaccine” and sryinge are seen in front of displayed Johnson&Johnson logo in this illustration taken, February 9, 2021. REUTERS/Dado Ruvic/Illustration/File Photo(Reuters) – A panel of expert advisers to the U.S. Food and Drug Administration (FDA) on Friday voted in favor of authorizing Johnson & Johnson’s COVID-19 vaccine for emergency […]

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Pfizer Asks FDA to Approve Storage of Vaccine in Standard Freezers

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Pfizer and BioNTech have submitted data to the US Food and Drug Administration (FDA) demonstrating that their COVID-19 vaccine can be safely stored at temperatures commonly found in pharmaceutical freezers and refrigerators. The data show that the vaccine is stable when […]

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Report: Trump Sicker With COVID-19 Than Portrayed

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Former President Donald Trump Former President Donald Trump’s condition after being diagnosed with COVID-19 in early October was more worrisome than portrayed for the public, The New York Times reports, citing four unnamed people familiar with his condition. The Times said […]