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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Portugal approves AstraZeneca jab for over-65s

Portugal, following a number of other European countries, has approved AstraZeneca’s COVID-19 vaccine for people aged 65 and over, the DGS national health authority said on Wednesday. “This decision takes into account data published in recent days indicating that the AstraZeneca-Oxford vaccine is effective for people aged over 65,” the authority said in a statement. […]

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FDA approves Pfizer's coronavirus vaccine for EUA

FDA panel endorses Pfizer coronavirus vaccine When will the treatment be available to the public? Infectious disease expert Dr. Amesh Adalja provides insight. The U.S. Food and Drug Administration (FDA) on Friday formally granted emergency approval for Pfizer and BioNTech’s coronavirus vaccine candidate, officially paving the way for widespread distribution of the long-awaited vaccine that […]

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Saudi Arabia approves Pfizer-BioNTech virus vaccine

Saudi Arabia on Thursday approved the use of the Pfizer-BioNTech novel coronavirus vaccine, state media reported, becoming the second Gulf country after Bahrain to green-light the drug. “The Saudi Food and Drug Authority (SFDA)… has approved the registration of Pfizer-BioNTech COVID-19 vaccine in the kingdom of Saudi Arabia,” it said in a statement released by […]

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FDA Approves Orladeyo

FDA Approves Orladeyo (berotralstat) as the First Oral, Once-Daily Therapy to Prevent Attacks in Hereditary Angioedema Patients RESEARCH TRIANGLE PARK, N.C., Dec. 03, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved oral, once-daily Orladeyo (berotralstat) for prophylaxis to prevent attacks of hereditary […]

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FDA approves drug for PET imaging of prostate cancer

(HealthDay)—The U.S. Food and Drug Administration approved the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer, the agency announced Tuesday. Approval of the radioactive diagnostic agent Gallium 68 PSMA-11 (Ga 68 PSMA-11) was granted to the University of California Los Angeles (UCLA) and the […]

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FDA Approves Danyelza

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. Food and Drug Administration […]