FDA Revokes Emergency Use of Solo Bamlanivimab for COVID

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) has granted Eli Lilly’s request to revoke emergency use authorization for the COVID-19 monoclonal antibody therapy bamlanivimab when used as a monotherapy, saying the evidence indicates that it is likely not effective against currently circulating variants. The agency said in […]

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FAQ: What to Know About the J&J Vaccine Pause

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. After receiving reports of a rare blood clot in people receiving the Johnson & Johnson COVID-19 vaccine, the FDA and the CDC have recommended a pause in the use of the vaccine, pending further investigation. Here is what you need to know: Why was the pause […]

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FDA Approves Trodelvy, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 7, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data […]

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FDA warns on unapproved CBD products marketed for pain relief

Fox News Flash top headlines for March 23 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. The Food and Drug Administration issued a warning to two companies selling over-the-counter products labeled as containing cannabidiol (CBD) without receiving the agency’s approval to do so. The agency has accused the companies, identified as Honest Globe Inc. and […]

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The FDA Just Authorized Johnson & Johnson’s Single-Shot Vaccine for Emergency Use—Here’s How it Stacks Up

As the Pfizer and Moderna COVID-19 vaccines continued to be given around the US (and the world at large), a third looks set to be authorized by the Food & Drug Administration (FDA). The Johnson & Johnson vaccine was developed by Janssen Pharmaceutical Companies—a Belgium-based division of the company—in collaboration with Beth Israel Deaconess Medical Center. It has "known benefits" […]

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FDA OKs First ‘Targeted Treatment’ for Rare DMD Mutation

The US Food and Drug Administration (FDA) has approved the antisense oligonucleotide casimersen (Amondys 45, Sarepta Therapeutics) injection for the treatment of patients with Duchenne muscular dystrophy (DMD) plus a rare DMD mutation, the agency has announced.  This particular mutation of the DMD gene “is amenable to exon 45 skipping,” the FDA noted in a press release. It added that […]

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Task Force Tackles FDA Lamotrigine Cardiac Risk Warning

A joint task force of the American Epilepsy Society (AES) and International League Against Epilepsy (ILAE) has issued an advisory to address concerns arising from a Food and Drug Administration (FDA) warning of cardiac risk in patients taking the antiseizure drug lamotrigine. The task force is concerned that the FDA warning is based on data not yet widely available, and […]

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FDA Approves Pediatric Indication for Xeomin (incobotulinumtoxina) for the Treatment of Chronic Sialorrhea

RALEIGH, N.C., December 21, 2020 — Merz Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of patients aged 2 years and older with chronic sialorrhea, or drooling. Xeomin is the first and only FDA-approved neuromodulator with this indication and was granted a priority review […]

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Trump congratulates the FDA as it green lights Moderna's COVID vaccine

Trump congratulates the FDA as it green lights Moderna’s COVID-19 vaccine: US authorizes second shot in seven days and readies to ship nearly 6 million doses by Christmas Trump tweeted: ‘Congratulations, the Moderna vaccine is now available!’  Regulators gave emergency approval to Moderna’s 94% effective COVID-19 vaccine on Friday evening FDA Commissioner Stephen Hahn called the availability of two vaccines […]

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FDA Approves Oxlumo

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 24, 2020– Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate […]

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