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Panel Mixed Vote on Merck’s Covid Drug
[1238 Words]
[ Price : $8.95]
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| FDA’s Antimicrobial Drugs Advisory Committee narrowly votes 13-10 to recommend an emergency use authorization for Merck’s oral antiviral molnupiravir for treating Covid-19 patients. |
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11/30/2021
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Teleflex Recalls Percutaneous Thrombolytic Device
[212 Words]
[ Price : $8.95]
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| Teleflex recalls its Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device Kit, 7FR, after receiving reports about the inner lumen becoming detached. |
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11/30/2021
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AstraZeneca, Merck sNDA for Lynparza
[196 Words]
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| FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2-negative high-risk early breast cancer. |
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11/30/2021
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Attorneys See Questions in LDT Policy Change
[2688 Words]
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| Three Hyman, Phelps attorneys say an HHS announcement withdrawing a Trump administration policy on FDA review of laboratory-developed tests leaves many questions unanswered. |
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11/30/2021
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Fennec Pharma Hit with 2nd Complete Response
[266 Words]
[ Price : $8.95]
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| FDA sends Fennec Pharmaceuticals a second complete response letter on its NDA for Pedmark (sodium thiosulfate, intravenous) for preventing ototoxicity (hearing loss) associated with cisplatin chemotherapy in pediatric patients with localized, non-metastatic, solid tumors. |
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11/30/2021
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Nominations for Radiation Safety Standards Panel
[70 Words]
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| Federal Register notice: FDA requests nominations for voting members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. |
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11/30/2021
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Real-World Data Guidance on Using Registries
[84 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products. |
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11/30/2021
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Comments on FDA Real-World Data Guidance
[2897 Words]
[ Price : $8.95]
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| Drug companies and other stakeholders respond to an FDA draft guidance on using electronic health records and claims data in real-world data studies. |
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11/30/2021
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Regulatory Review Period for Zepzelca
[100 Words]
[ Price : $8.95]
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| Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pharma Mar’s Zepzelca (lurbinectedin). |
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11/29/2021
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