HCPLive 5 Stories in Under 5: Week of 09/07
Update: 2025-09-15
Description
Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!
Interested in a more traditional, text rundown? Check out the HCPFive!
Top 5 Healthcare Headlines for September 5-September 14, 2025:
1. FDA Removes Sparsentan (Filspari) Advisory Committee Meeting for FSGS sNDA
The FDA determined no advisory committee is needed for sparsentan’s sNDA in FSGS, which remains under review with a January 2026 decision date.
2. Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market
Intercept will withdraw obeticholic acid from the US PBC market after an FDA request and related clinical trial holds.
3. FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials
The FDA accepted a proposal to qualify FibroScan liver stiffness measurement as a surrogate endpoint for MASH trials, supported by multiple industry partners.
4. FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD
eGenesis received FDA clearance to begin clinical testing of a genetically engineered porcine kidney transplant in patients with ESKD.
5. First in Class Cat, Birch Allergen Blockers Succeed in Phase 3 Trials
Regeneron reported phase 3 success for novel allergen-blocking antibodies targeting cat and birch allergies, with confirmatory trials planned.
Interested in a more traditional, text rundown? Check out the HCPFive!
Top 5 Healthcare Headlines for September 5-September 14, 2025:
1. FDA Removes Sparsentan (Filspari) Advisory Committee Meeting for FSGS sNDA
The FDA determined no advisory committee is needed for sparsentan’s sNDA in FSGS, which remains under review with a January 2026 decision date.
2. Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market
Intercept will withdraw obeticholic acid from the US PBC market after an FDA request and related clinical trial holds.
3. FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials
The FDA accepted a proposal to qualify FibroScan liver stiffness measurement as a surrogate endpoint for MASH trials, supported by multiple industry partners.
4. FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD
eGenesis received FDA clearance to begin clinical testing of a genetically engineered porcine kidney transplant in patients with ESKD.
5. First in Class Cat, Birch Allergen Blockers Succeed in Phase 3 Trials
Regeneron reported phase 3 success for novel allergen-blocking antibodies targeting cat and birch allergies, with confirmatory trials planned.
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