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14 September, 2026
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1. BioNTech spells out survival win for gotistobart ahead of pivotal readout
2. GSK to wind down German vaccine factory due to lack of demand 
3. FDA looks into reassessing criteria around rare disease trials, endpoint selection
4. Seeking a fresh start, Novo drops the 'Nordisk'
5. Scholar Rock gets FDA nod for spinal muscular atrophy drug  
6. Definium says its LSD drug notched another Phase 3 win in anxiety disorder
7. AstraZeneca’s next-gen SERD disappoints in untreated advanced breast cancer
more stories
 
Nicole DeFeudis
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I’m tuning in to the FDA’s public hearing on the use of psychedelic drugs. So far, several mental health experts have called on the agency to require proper training for providers administering psychedelics. “The future of psychedelic medicine will not be defined only by the medicines we approve, but by the professionals we prepare to steward them,” said Michaela Vogt, co-founder of a Colorado wellness center called NeuroAlchemy. Stay tuned for more coverage.

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Nicole DeFeudis
Senior Reporter, Endpoints News
@Nicole_DeFeudis
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by Lei Lei Wu

BioN­Tech de­liv­ered a com­pelling piece of ev­i­dence Mon­day sup­port­ing the de­vel­op­ment of its CT­LA-4 an­ti­body go­tis­to­bart in lung can­cer.

Pre­vi­ous­ly treat­ed lung can­cer pa­tients who...

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by Anna Brown

GSK is clos­ing a fac­to­ry in Ger­many and lay­ing off about 650 work­ers as de­mand for egg-based flu vac­cines de­clines, a spokesper­son told End­points News...

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3
by Zachary Brennan

As more rare dis­ease treat­ments make their way to the FDA, the agency on Mon­day called for fur­ther out­side in­put as it grap­ples with how...

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by Anna Brown

In a brand re­boot, No­vo Nordisk is short­en­ing its name and adopt­ing a new cul­ture strat­e­gy af­ter a se­ries of set­backs this year.

From Mon­day...

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5
by Anna Brown

Schol­ar Rock has won FDA ap­proval for its drug treat­ing a rare mus­cle-wast­ing dis­ease, af­ter fac­ing de­lays due to a trou­bled man­u­fac­tur­ing fac­to­ry.

The in­jectable...

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6
by Anna Brown

Defini­um Ther­a­peu­tics re­port­ed re­sults Mon­day for its third Phase 3 read­out this year on its oral LSD can­di­date, called DT120, and is gear­ing up for...

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