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FDA Must Correct on Rare Diseases, Not Overcorrect: Column

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A RealClear Health column urges FDA not to overcorrect as it reconsiders its approach to investigational rare disease therapies.

Rescind Filing of 2 Zydus Applications: Gilead

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Gilead petitions FDA to rescind its acceptance for filing of two Zydus 505(b)(2) applications for drugs that Gilead says are dupli...

Neptune Medical Robotic Endoscopy Cleared

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FDA clears a Neptune Medical 510(k) for its Triton 1 System, a robotic system for next-generation flexible endoscopy.

Sen. Warren Continues to Push for TrumpRx Contracts

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Sen. Elizabeth Warren says she is continuing to push Trump officials to release the actual contracts that have been signed with dr...

Prepare for Enhanced FDA/SEC Oversight: Sidley

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Sidley attorneys say regulated companies should expect heightened federal government oversight due to a recent information-sharing...

Senate Looks to Rush Overtons FDA Head Nomination: Report

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The Senate HELP Committee prepares to hold a confirmation hearing for FDA commissioner nominee Heidi Overton as soon as next week.

FDA Adds Kybella Warning Over Serious Risks From Off-Label Injections

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FDA approves new safety warnings for AbbVies Kybella (deoxycholic acid) after identifying serious adverse events when the fat-diss...

FDA Finalizes Guide on Use of Buffy Coat Blood Processing

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FDA finalizes a guidance intended to facilitate development of blood collection, processing and storage systems that would allow U...

Bill to Make Pediatric Rare Disease Voucher Permanent

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Six House members introduce bipartisan legislation to make the FDA Rare Pediatric Disease Priority Review Voucher Program permanen...

Cassidy Remains Noncommittal on Overton FDA Nomination After Meeting

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Senate HELP Committee chairman Bill Cassidy (R-La.) keeps mum on any potential support for FDA commissioner nominee Heidi Overton ...