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A BIT of reform, a lot of opportunities
17 Mar 2025 02:21 GMT
… too.
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BITs find their genesis in the …
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REGENXBIO Inc. (NASDAQ:RGNX) Q4 2024 Earnings Call Transcript
15 Mar 2025 12:21 GMT
… around potentially going to an ad com for 202 once you have …
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Ellen Degeneres Just Put Her Last Home in the U.S. On The Market
13 Mar 2025 13:50 GMT
… Santa Barbara. And according to AD.com, “The property comes with its …
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FDA Ad Com votes in favor of TransMedics' OCS Liver System
15 Jul 2021 06:44 GMT
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Biogen rallies 31% ahead of Ad Com meeting on Alzheimer's med aducanumab
04 Nov 2020 17:49 GMT
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FDA Ad Com thumbs down on Neovasc Reducer; shares plummet 36%
28 Oct 2020 12:39 GMT
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FDA Ad Com tomorrow on development/authorization of COVID-19 vaccines
21 Oct 2020 19:06 GMT
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FDA Ad Com this month to clarify COVID-19 vaccine authorization requirements
06 Oct 2020 16:36 GMT
The FDA's Vaccines and Related Biological Products Advisory Committee will meet on Thursday, October 22, to discuss pre- and post-licensure clinical trials needed to further evaluate the immunogenicity and duration of effectiveness of COVID-19 vaccines …
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FDA postpones Ad Com meeting on TransMedics donor heart management system
28 Sep 2020 22:02 GMT
TransMedics (NASDAQ:TMDX) has announced that the FDA has temporarily postponed the Advisory Committee (AdCom) meeting to review its premarket approval application for its OCS Heart, which was originally scheduled for October 7, to have more time to review …
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FDA Ad Com thumbs down on mortality benefit claim for Glaxo's Trelegy Ellipta
31 Aug 2020 21:24 GMT
The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 14-1 that the results from the IMPACT study evaluating GlaxoSmithKline's (GSK +0.2%) Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder oral inhalation) in …