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9 September, 2026
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top stories
1. FDA should follow EMA's lead on drug rejection disclosures, researchers say
2. Encoded closes $275M Series F for Dravet syndrome drug
3. ARPA-H selects companies to build AI tools for heart disease
4. Current heads of CBER, CDER snag permanent jobs
5. From lab banter to a Lasker Award: The science behind narcolepsy
6. Beeline Medicines reports promising mid-stage lupus data
7.
news briefing
Compass posts positive psilocybin data; Solstice makes $225M debut
8. Evommune's lead drug flunks its second I&I trial this summer
more stories
 
Lydia Ramsey Pflanzer
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Today's Lasker Award win by the scientists who uncovered key connections between narcolepsy and orexin reminded me that the field is getting hot. Max Bayer a few months back had a good read on what's ahead for the orexin market. 

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Lydia Ramsey Pflanzer
Deputy Editor, Endpoints News
1
by Zachary Brennan

The FDA's ma­jor shift in Sep­tem­ber 2025 to be­gin pub­lish­ing drug re­jec­tion let­ters is still an evolv­ing process. But mov­ing for­ward, the US agency should...

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2
by Max Bayer

En­cod­ed Ther­a­peu­tics has tacked on $275 mil­lion in new cap­i­tal, clos­ing a Se­ries F round led by GV and an undis­closed health­care in­vestor.

The pre­ci­sion...

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3
by Shelby Livingston

Up­Doc, Tem­pus AI and At­man Health will par­tic­i­pate in a new pro­gram that aims to build FDA-au­tho­rized agen­tic AI tools to care for peo­ple with...

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4
by Max Bayer

The FDA has made per­ma­nent the lead­ers of CDER and CBER, sta­bi­liz­ing key agency posts as a new com­mis­sion­er awaits con­fir­ma­tion.

The de­ci­sion was an­nounced...

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Health Tech Day 2026
The entire healthcare ecosystem is more Silicon Valley-ified than ever before. What tech has actually changed? Is biopharma behind? Find out, join us for Health Tech day.
5
by Lei Lei Wu

The path to un­der­stand­ing a com­mon sleep dis­or­der start­ed with lab ban­ter and trav­eled through mice, dogs and more re­cent­ly, the flu virus.

Now, the...

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6
by Max Bayer

The busi­ness of ad­vanc­ing shelved phar­ma as­sets con­tin­ues to reap ben­e­fits, this time for Bee­line Med­i­cines and a lu­pus can­di­date pro­vid­ed by Bris­tol My­ers Squibb.