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Atara, Pierre Fabre will get another shot at FDA approval Read in browser
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top stories
1. FDA Commissioner Makary resigns
2. Post-Hoc: What brought down the FDA commissioner 
3. Atara, Pierre Fabre will get another shot at FDA approval, a week after Prasad's departure
4. European regulators greenlight first clinical test of GLP-1 gene therapy
5. EU reaches provisional deal on Critical Medicines Act
Nicole DeFeudis
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Marty Makary resigned from the FDA on Tuesday, following reports that President Donald Trump had signed off on a plan to fire him. Makary’s final weeks were marked by pressure on a range of issues, from flavored vapes to drug approval decisions. Drew Armstrong dissected Makary’s tumultuous tenure in a Post-Hoc piece here. Tomorrow, he and senior reporter Max Bayer will discuss where the agency goes next at the Financial Times’ US Pharma and Biotech Summit. Click here for details on how to tune in.

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Nicole DeFeudis
Editor, Endpoints News
@Nicole_DeFeudis
Marty Makary (Jose Luis Magana/AP Images)
1
by Max Bayer

FDA Com­mis­sion­er Mar­ty Makary has re­signed af­ter his job sta­tus hung in the bal­ance for days.

Pres­i­dent Don­ald Trump con­firmed the news Tues­day in a...

Read full story
2
by Drew Armstrong

Mar­ty Makary nev­er stood a chance.

Over the last few days, the now-for­mer FDA com­mis­sion­er had been left to twist in the wind, af­ter head­lines...

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3
by Max Gelman

There's new life for a twice-re­ject­ed T cell ther­a­py from Atara Bio­ther­a­peu­tics and Pierre Fab­re Phar­ma­ceu­ti­cals.

US reg­u­la­tors are will­ing to re­con­sid­er us­ing a Phase...

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Harith Rajagopalan, Fractyl Health CEO
4
by Ryan Cross

Drug de­vel­op­ers are rac­ing to make gene ther­a­piesthat could re­place chron­ic GLP-1 in­jec­tions and pills with a one-and-done treat­ment. Now, a com­pa­ny based just...

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5
by Anna Brown

The Crit­i­cal Med­i­cines Act reached its next mile­stone on Tues­day, af­ter the Eu­ro­pean Par­lia­ment and the Coun­cil pro­vi­sion­al­ly vot­ed it through.

The pro­posed reg­u­la­tion aims...

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