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Talvey Becomes J&J’s Second Multiple Myeloma Bispecific to Score FDA Approval

XTalks

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. Results were similar at the higher 0.8

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FDA Authorizes Pfizer COVID-19 Vaccine for Children 5 to 11 + Genentech’s Ocular Implant for Macular Degeneration – Xtalks Life Science Podcast Ep. 35

XTalks

In this episode, Ayesha discusses the FDA’s authorization of Pfizer/BioNTech’s COVID-19 vaccine for children between five and 11 years of age. The team also learned about the FDA approval of Genentech’s new ocular implant drug delivery system, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD).

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2021 Year in Review: Leveraging New Technologies to Drive Innovation in the Life Sciences

XTalks

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year 2021 was all about continuing innovations in the life sciences. Life Science Innovations: Malaria and Influenza Vaccines.

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Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

XTalks

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

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World AIDS Day 2023: New and Promising Treatments for HIV/AIDS

XTalks

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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Tzield Gets FDA Nod to Become First Approved Drug to Delay Onset of Type 1 Diabetes

XTalks

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. Related: GLP-1 Agonists for Diabetes: Mounjaro Versus Ozempic.

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Top 5 Most Promising FDA New Drug Approvals Expected in the Second Half of 2024

XTalks

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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