Category: FDA
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FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
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This section is Partnership Content supplied The content in this section is supplied by GlobeNewswire for the purposes of distributing press releases on behalf of its clients. Postmedia has not reviewed the content. by GlobeNewswire Breadcrumb Trail Links GlobeNewswire Author of the article: Published Jan 26, 2025 • 17 minute…
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FDA OKs sales of Zyn nicotine pouches, citing health benefits for adult smokers
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Breadcrumb links PMN BMN Business Article writer: Associated Press Matthew Perrone Posted on January 16, 2025 • 2 min read You can save this article by registering for free here. Or log in if you have an account. FILE – Containers of Zyn, a smokeless nicotine pouch, are displayed for…
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FDA Accepts LEQEMBI® (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
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This section is Partnership Content supplied The content in this section is supplied by GlobeNewswire for the purposes of distributing press releases on behalf of its clients. Postmedia has not reviewed the content. by GlobeNewswire Breadcrumb Trail Links GlobeNewswire Author of the article: Published Jan 13, 2025 • 16 minute…
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Cambridge-based CMR Surgical secures FDA approval for revolutionary portable surgical robot
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CMR Surgical, a Cambridge-based medical technology company, has made significant progress after receiving marketing authorization from the US Food and Drug Administration (FDA) for its Versius Surgical portable system. This represents an important step in the world’s largest healthcare market, enabling CMR to prepare for sales of the Versius system…
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US FDA puts Kezar Life Sciences’ lupus treatment trial on hold after patient deaths By Reuters
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(Reuters) – The US Food and Drug Administration imposed a clinical suspension on the drug Kezar Life Sciences (NASDAQ:)’ trial of an experimental drug for lupus, the company said Friday. The FDA’s decision comes after the company said it had temporarily halted a mid-stage trial of the drug, zetomipzomib, to…
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Genus reports progress amid market challenges, eyes FDA approval By Investing.com
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Genus PLC (GNS), a leading animal genetics company, reported its preliminary results for the fiscal year ended June 30, 2024, showcasing resilience and strategic advancements despite challenging trading conditions. CEO Jorgen Kokke highlighted the company’s progress in key areas such as the commercialization of its Porcine Reproductive and Respiratory Syndrome…
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Emergent stock jumps as FDA clears smallpox vaccine for people at high risk of mpox (NYSE:EBS)
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Emerging Bio-Solutions (New York: EBS) stocks jumped 23% pre-market Friday The U.S. Food and Drug Administration (FDA) has approved expanded use of the company’s ACAM2000 smallpox vaccine to include people at risk of smallpox infection. Earlier this month, the World Health Organization announced The outbreak of monkeypox, formerly known as…
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Emergent stock jumps as FDA clears smallpox vaccine for people at high risk of mpox (NYSE:EBS)
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Emerging Bio-Solutions (New York: EBS) stocks jumped 23% pre-market Friday The U.S. Food and Drug Administration (FDA) has approved expanded use of the company’s ACAM2000 smallpox vaccine to include people at risk of smallpox infection. Earlier this month, the World Health Organization announced The outbreak of monkeypox, formerly known as…
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US FDA approves updated COVID shots ahead of fall and winter By Reuters
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Written by Maryam Sani and Manas Mishra (Reuters) – The U.S. Food and Drug Administration on Thursday approved updated COVID-19 vaccines from Pfizer Inc. Pfizer (New York Stock Exchange:) and accident (NASDAQ:) is targeting a new variant of the disease, just in time for a vaccination campaign in the fall.…
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US FDA flags dosing risks from compounded versions of Novo’s weight-loss drug By Reuters
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(Reuters) – The U.S. Food and Drug Administration on Friday warned patients and doctors about dosing errors linked to combination versions of Novo Nordisk’s weight-loss and diabetes drugs. The health regulator said it had received reports of adverse events, some requiring hospitalization, that may have been linked to overdoses caused…
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Agenus stock cut at Baird on FDA feedback (NASDAQ:AGEN)
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George Clerc After falling nearly 60% in the previous session, Agenus shares (NASDAQ: Agen) Decreased by ~5% Shares of Baird fell Friday after the company downgraded its rating, citing FDA reactions to its colorectal cancer treatment combination BOT/BAL that led to selling. After meeting with Food and Drug Administration, Agnusan…
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New Alzheimer’s drug treatment from Eli Lillly wins FDA approval
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Eli Lilly & Co. has won U.S. approval for an Alzheimer’s treatment, the second drug to slow the progression of the brain-robbing disease that affects 6 million Americans. It’s a huge win for Lilly and its investors, who have been eagerly awaiting the drug since it hit the market. show…
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FDA OKs first menthol e-cigarettes
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The Food and Drug Administration on Friday approved the first menthol-flavored product Electronic cigarettes For adult smokers, recognizing that vaping flavors can reduce the harms of traditional tobacco smoking. The FDA said it has authorized four e-cigarettes containing menthol from Njoy, the e-cigarette brand recently acquired by tobacco giant Altria,…
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Ascendis stock falls as FDA delays TransCon PTH review
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Grandparents Editorial/iStock via Getty Images Ascendis Pharma (ASND) announced Tuesday that the U.S. Food and Drug Administration (FDA) has postponed the timeline for completing its review of the company’s experimental hypoparathyroidism treatment, TransCon PTH. The Food and Drug Administration considered the information provided by the company Regarding the New Drug…