Zachary Brennan
Senior Editor at Endpoints News
Senior Editor, Endpoints News - covering the FDA, Capitol Hill, and biotech/pharma - reach me at [email protected], Signal: zacharybrennan.20
Articles
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1 week ago |
endpts.com | Zachary Brennan
After a slight delay, the FDA rejected Stealth BioTherapeutics’ Barth syndrome drug application for elamipretide, the company said early Thursday, but will consider a resubmission … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
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1 week ago |
endpts.com | Zachary Brennan
FDA Commissioner Marty Makary, newly minted CBER chief Vinay Prasad and Principal Deputy Commissioner Sara Brenner are visiting six US cities in June and July … Sign up to read this article for free. Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
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1 week ago |
endpts.com | Zachary Brennan
Canadian cell therapy biotech Sernova said Sunday that its board chairman Ross Haghighat has resigned after being indicted by the Department of Justice Sign up to read this article for free. Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
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2 weeks ago |
endpts.com | Zachary Brennan
Nearly one out of every 20 staff in the FDA offices that oversee drugs and biologics are gone after the Trump administration Sign up to read this article for free. Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
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2 weeks ago |
endpts.com | Zachary Brennan
The House of Representatives on Thursday morning passed President Donald Trump’s tax cut package, with steep Medicaid cuts, PBM reforms and changes to the government’ … Sign up to read this article for free. Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
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“We are taking a look at the application process. We’re asking ourselves: Can certain materials be submitted in advance so approvals can be quicker?” Makary said Thursday at an FDA roundtable on cell and gene therapies. - https://t.co/g5v3kWIaIN
The FDA is hosting a roundtable this afternoon at White Oak with 100 pharma CEOs and heads of R&D (...it's not open to the press.)
FDA's Vinay Prasad says he will 'rapidly' push forward rare disease advances - https://t.co/nganXsR8qx
