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Reconsider mifepristone, court tells FDA Read in browser
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top stories
1. Capricor shares plunge after FDA says DMD therapy lacks efficacy ahead of adcomm
2. Virginia federal judge says FDA should reconsider mifepristone restrictions
3. Six wellness peptides win backing from FDA advisory committee, setting up future agency action
4. The patent cliff is looming and CDMOs need to be prepared, Fujifilm CEO says
5. Sarepta turns to Michael Severino as CEO, looking to move past recent turmoil
6. MapLight’s schizophrenia drug dampens once-daily hopes despite Phase 2 win
7. Updated: AstraZeneca foresees blockbuster sales for Claudin 18.2 ADC, but Ultomiris flops in rare disease
more stories
 
Kevin Miller
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It was a No-Mercy Monday for companies with disappointing news. Capricor's stock lost two-thirds of its value after the FDA said its DMD therapy lacked efficacy, while MapLight took a similar beating when a once-daily dose of its schizophrenia drug missed its endpoint.

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Kevin Miller
Deputy Editor, Endpoints News
1
by Zachary Brennan

The FDA is again ques­tion­ing the ef­fi­ca­cy of Capri­cor's cell ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy, this time ahead of an ad­vi­so­ry com­mit­tee meet­ing on Wednes­day...

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2
by Nicole DeFeudis

At a time when the fed­er­al gov­ern­ment is eval­u­at­ing re­stric­tions on med­ica­tion abor­tion, a fed­er­al judge de­ter­mined that the last ad­min­is­tra­tion im­posed too many.

A...

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3
by Shelby Livingston

Af­ter two days of meet­ings, an FDA ad­vi­so­ry com­mit­tee last week vot­ed to lift re­stric­tions on six pop­u­lar health and well­ness pep­tides, set­ting aside FDA...

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Lars Petersen, Fujifilm Biotechnologies CEO
4
by Anna Brown

As drug­mak­ers pre­pare for the loom­ing bio­phar­ma patent cliff, 2026 has so far been a year for deal­mak­ing. Now, con­tract man­u­fac­tur­ers need to broad­en...

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Michael Severino, new Sarepta CEO
5
by Lei Lei Wu

Sarep­ta Ther­a­peu­tics has found its new CEO as it seeks to re­cov­er from a calami­tous past year.

Michael Sev­eri­no will re­place the com­pa­ny’s long­time leader...

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