#FDAFastTrack

@longevitytech.bsky.social

2 months ago

FDA designation accelerates development of a novel ALS treatment that targets disease biology, not just symptoms.

longevity.technology/news/vectory...

#longevity #ALS #neurodegeneration #FDAFastTrack #diseasemodifying #biotech #healthinnovation

@d-and-d-world.bsky.social

4 months ago

Enterome’s lymphoma drug wins FDA fast track designation The company is exploring EO2463’s efficacy in relapsed or refractory settings in a Phase I/II trial, with plans to start Phase III registrational trial in a “watch-and-wait” iNHL patient population

Enterome’s OncoMimics immunotherapy EO2463 gains FDA Fast Track for follicular lymphoma, paving the way for Phase III trials in in the low-tumor-burden “watch-and-wait” setting.

#News #Lymphoma #FDAfasttrack #CancerResearch #Enterome #Oncology

Phalguni Deswal

@phalguniddw.bsky.social

4 months ago

Enterome’s lymphoma drug wins FDA fast track designation The company is exploring EO2463’s efficacy in relapsed or refractory settings in a Phase I/II trial, with plans to start Phase III registrational trial in a “watch-and-wait” iNHL patient population

Enterome’s OncoMimics immunotherapy EO2463 gains FDA Fast Track for follicular lymphoma, paving the way for Phase III trials in in the low-tumor-burden “watch-and-wait” setting.

#News #Lymphoma #FDAfasttrack #CancerResearch #Enterome #Oncology

@d-and-d-world.bsky.social

6 months ago

US FDA fast-tracks Cereno Scientific’s PAH drug CS1 Cereno Scientific is preparing for a global Phase IIb trial for CS1, scheduled to begin in the first half of 2026.

Cereno Scientific secures FDA Fast Track designation for its PAH drug CS1, advancing toward a Phase IIb trial. A key step in bringing new treatment options to patients with urgent unmet needs. 🚀💊

#News #FDAFastTrack #PAH #Biotech #RareDisease #DrugDevelopment #CerenoScientific

Phalguni Deswal

@phalguniddw.bsky.social

6 months ago

US FDA fast-tracks Cereno Scientific’s PAH drug CS1 Cereno Scientific is preparing for a global Phase IIb trial for CS1, scheduled to begin in the first half of 2026.

Cereno Scientific secures FDA Fast Track designation for its PAH drug CS1, advancing toward a Phase IIb trial. A key step in bringing new treatment options to patients with urgent unmet needs. 🚀💊

#News #FDAFastTrack #PAH #Biotech #RareDisease #DrugDevelopment #CerenoScientific

@oregonbioincubator.bsky.social

8 months ago

🚨 Final Session Alert! 🚨

Join us Tue, July 15 | 12–1 PM (PDT) on Zoom for FDA Programs to Expedite Drug Development with Elizabeth Gordon, sponsored by RAIN Catalysts.

Free to attend. Register now: zurl.co/nR7ku

#FDAFastTrack #DrugDevelopment #BiotechEvents