Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of Darzalex Faspro® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Darzalex Faspro® is the […]

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FDA Approves Riabni

FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan THOUSAND OAKS, Calif., Dec. 17, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Riabni (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis), and Microscopic Polyangiitis […]

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Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.

Thursday, December 10, 2020 FDA expected to make a decision on Emergency Use Authorization in the coming days Positive vote based on totality of scientific evidence presented by the companies, including Phase 3 efficacy and safety data If authorized, BNT162b2 would be the first COVID-19 vaccine available in the U.S. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) […]

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FDA Approves Gallium 68 PSMA-11

FDA Approves Gallium 68 PSMA-11 as the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer December 01, 2020 — Today, the U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. Ga 68 PSMA-11 […]

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Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19

NEW YORK & MAINZ, Germany–(BUSINESS WIRE) December 02, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase […]

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Moderna Announces Amendment to Current Supply Agreement with United Kingdom Government for an Additional 2 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 29, 2020– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the UK government for an additional 2 million doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to the United Kingdom beginning in March 2021. The UK government has now secured 7 million doses of […]

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Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 16, 2020– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in […]

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FDA Approves Alkindi Sprinkle

FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency September 30, 2020 — Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the US Food and Drug Administration (FDA) has approved Alkindi Sprinkle (hydrocortisone oral granules) as replacement therapy in pediatric patients with adrenocortical insufficiency (AI). This approval […]

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Evolution of approval, regulation processes for drugs explored

(HealthDay)—The U.S. approval and regulation processes for pharmaceutical agents have evolved during the last four decades, according to a study published in the Jan. 14 issue of the Journal of the American Medical Association. Jonathan J. Darrow, J.D., from Harvard Medical School in Boston, and colleagues describe the evolution of laws and standards affecting drug testing, use of new approval […]

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Two more heartburn meds recalled due to possible carcinogen

(HealthDay)—The U.S. Food and Drug Administration is adding to a list of recalled lots of popular heartburn medications—including generic forms of Zantac—because the pills might contain small amounts of a suspected carcinogen. The substance, called N-Nitrosodimethylamine (NDMA), is an environmental contaminant that can be found in water and foods and has been classified as a “probable human carcinogen” by the […]

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