Recent court decision pushes FDA to reject and reclassify drug-device combo, crushing shares

Zachary Brennan

Senior Editor

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions …

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Recent court decision pushes FDA to reject and reclassify drug-device combo, crushing shares

Zachary Brennan

Senior Editor

Sign up to read this article for free.

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Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Pfiz­er’s prostate can­cer da­ta leak shows promis­ing re­sults in ear­ly-stage study

What will phar­ma's share buy­back shop­ping spree mean for M&A?

Trump 2.0 blog: Way­back Ma­chine is in­suf­fi­cient for US health da­ta, judge says

No­var­tis re­turns for its an­ti­co­ag­u­lant in up to $3.1B buy of Black­stone’s An­thos

Bio­haven lands pri­or­i­ty re­view on sec­ond-chance ap­pli­ca­tion for neu­rode­gen­er­a­tive drug

Re­duc­ing risk in drug de­vel­op­ment: The im­por­tance of val­i­dat­ed MRD test­ing in lym­phoid can­cers

Recent court decision pushes FDA to reject and reclassify drug-device combo, crushing shares

Pfizer’s prostate cancer data leak shows promising results in early-stage study

What will pharma's share buyback shopping spree mean for M&A?

Trump 2.0 blog: Wayback Machine is insufficient for US health data, judge says

Novartis returns for its anticoagulant in up to $3.1B buy of Blackstone’s Anthos

Biohaven lands priority review on second-chance application for neurodegenerative drug

Reducing risk in drug development: The importance of validated MRD testing in lymphoid cancers