Palvella Therapeutics Reports Full Year 2025 Financial Results and Provides Corporate Update

New Drug Application (NDA) for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs) ...
Taiwan News

Palvella Therapeutics Highlights Continued Progress Across Rare Skin Disease Pipeline with Two Poster Presentations at the 2026 American Academy of Dermatology Annual Meeting

Palvella is developing QTORIN™ pitavastatin for disseminated superficial actinic porokeratosis (DSAP), with a Phase 2 trial anticipated to begin in the second half of 2026. No FDA-approved therapies ...
The Hill

FDA proposes new treatment approval pathway for ultrarare diseases

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed ...
FierceBiotech

UPDATED: FDA illuminates new approval pathway for bespoke gene editing therapies

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
STAT

FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications

Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients. You can reach Jason ...
Becker's Hospital Review

FDA unveils pathway for ultra-rare disease therapies

The FDA has released draft guidance outlining an approval pathway for individualized therapies aimed at ultra-rare diseases, building on a framework first outlined by agency leaders in November. The ...
eLife

Abnormal shear stress induces ferroptosis in endothelial cells via KLF6 downregulation

This study presents valuable findings on the role of KLF6 in in vitro endothelial cells exposed to altered (high or low) shear stress with a customized microfluidic device to investigate mechanisms of ...
Frontiers

Farnesol, the farnesol pathway, and the immune-gut-brain axis

Experimental models and clinical evidence suggest that the gut and the central nervous system (CNS) interact in a multifactorial, bidirectional manner. A third player, the immune system, has recently ...
WAFF

City of Owens Cross Roads releases statement addressing Pathway facility

OWENS CROSS ROADS, Ala. (WAFF) - The City of Owens Cross Roads released a statement addressing the Pathway facility. Owens Cross Roads City Council voted in November to pursue legal action toward the ...
FierceBiotech

UPDATED: Prasad, Makary unveil new FDA path for accelerating custom gene editing therapies

In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory pathway that could trigger a seismic shift in how bespoke gene editing therapies ...
Reuters

Clearlake to buy investment manager Pathway Capital in private markets push

Nov 12 (Reuters) - Clearlake Capital Group said on Wednesday it will buy investment manager Pathway Capital Management, as the buyout firm looks to expand its presence in the red-hot private markets ...
WHNT

Owens Cross Roads City Council to discuss future of Pathway facility on Thursday

OWENS CROSS ROADS, Ala. (WHNT) – A special city council meeting will take place in Owens Cross Roads on Thursday to discuss the future of the Pathway of Madison County facility. The facility for ...