All News #Library
Rare Diseases
US FDA Approves First Treatment for Rare Disease in Males
20 Sep 2025 //
REUTERS
Stealth, Barth Community Await FDA Verdict With All at Stake
16 Sep 2025 //
BIOSPACE
Stealth`s Flight Path Returns to FDA for Rejected Barth Drug
23 Aug 2025 //
BIOSPACE
Stealth Bio Submits Rare Disease Application for The Third Time
19 Aug 2025 //
PR NEWSWIRE
StealthBio Submits Rare Disease Application for The Third Time
18 Aug 2025 //
FIERCE BIOTECH
FDA Rejects Reconsideration of Stealth`s Ultrarare Disease Med
08 Aug 2025 //
FIERCE BIOTECH
Stealth to Cut Jobs After FDA Rejects Therapy for Rare Disorder
29 May 2025 //
REUTERS
FDA delays decision on Stealth` rare genetic disorder drug
30 Apr 2025 //
REUTERS
FDA Panel Votes For Elamipretide In Barth Syndrome
11 Oct 2024 //
PR NEWSWIRE
After agony, FDA adcomm favors Stealth`s ultra-rare disease drug
10 Oct 2024 //
FIERCE BIOTECH
FDA again raises doubts on Stealth`s ultra-rare disease drug ahead
10 Oct 2024 //
ENDPTS
Stealth Biotherapeutics` Barth Syndrome NDA Receives Priority Review Designation
07 May 2024 //
PR NEWSWIRE
Stealth Bio gets FDA adcomm for previously rejected ultra-rare disease drug
09 Apr 2024 //
ENDPTS
Stealth Announces FDA Acceptance of NDA for Elamipretide for the Barth Syndrome
08 Apr 2024 //
PR NEWSWIRE
Rare disease drugmaker files for approval on adequate trial data; FDA objects
25 Aug 2021 //
ENDPTS
Stealth BioTherapeutics Joins the Rare Disease Company Coalition
07 Jul 2021 //
PR NEWSWIRE
Stealth & Evotec Advance New Compound
15 Aug 2018 //
CONTRACT PHARMA
Another IPO frenzy? Two US biotechs head to Hong Kong for a public market debut
05 Jul 2018 //
ENDPTS

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