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community Good news for stem cells hair therapies - US federal judge: using patients' stem cells does NOT fall under FDA jurisdiction

26 upvotes 4 years ago

A US federal judge ruled that using patients' stem cells for medical treatments is not under FDA jurisdiction, potentially speeding up development of stem cell-based hair loss therapies. Some users are optimistic about increased research and development, while others express skepticism about the ruling's impact on safety and efficacy standards.

community Popular hair loss drug linked to higher suicide risk: compared to non-users, finasteride (Proscar/ Propecia) users have a markedly increased risk of depression, anxiety, and suicidal thoughts. Over 30 years of observation, 19,320 suicides were expected.

494 upvotes 11 months ago

Finasteride users may have an increased risk of depression, anxiety, and suicidal thoughts, though some attribute these issues to hair loss itself. The link between finasteride and mental health effects is debated, with varying user experiences.

community FDA Policy Shift Explained: What It Actually Means for PP405, VDPHL-01, Breezula and Hair Loss Drug Timelines

in Research/Science 42 upvotes 7 months ago

The FDA policy change may speed up approval for hair loss drugs like PP405, VDPHL-01, and Breezula by potentially eliminating the need for a second confirmatory Phase 3 trial. Approval timelines could be as early as 2028 for some treatments if Phase 3 results are strong.

community US FDA will now default to only one clinical trial for drug applications, will this accelerate the release of PP405 and other drugs in clinical trials?

13 upvotes 7 months ago

The FDA will now require only one clinical trial for drug approval, potentially speeding up the release of hair loss treatments like PP405. Pelage is expected to present full results of PP405 Phase 2a trials and move to Phase III in mid-2026.

community New warning by FDA on topical finasteride

in Research/Science 194 upvotes 1 year ago

The FDA warned that topical finasteride can cause serious side effects like sexual dysfunction and brain fog, similar to oral finasteride. Compounded topical formulations pose additional risks due to lack of regulation.

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Research

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research Repurposing FDA approved drugs for psoriasis indications through integrated molecular docking, one-SVM algorithm, and molecular dynamics simulation approaches

July 2025 in “Scientific Reports”

In this study, researchers explored drug repurposing as a potential strategy for treating psoriasis and identified Pioglitazone, Trimipramine, and Dimetindene as promising candidates for this indication, based on molecular docking and predictive algorithms.

research Ovary and uterus related adverse events associated with statin use: an analysis of the FDA Adverse Event Reporting System

11 citations , July 2020 in “Scientific Reports”

This study suggests that statins may be linked to various ovary and uterus related adverse events, highlighting the need for monitoring in clinical practice.

research Safety Profile of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: A Disproportionality Analysis of FDA Adverse Event Reporting System

58 citations , March 2020 in “Scientific Reports”

This study mapped the safety profile of EGFR-TKIs by analyzing FDA adverse event reports, highlighting unexpected reactions like intestinal obstruction and hypokalaemia with gefitinib and erlotinib.

research Comparative Analysis of Labeling and Claim Substantiation Requirements for Herbal Hair Products across Different Regulatory Jurisdictions

December 2025 in “International Journal of Newgen Research in Pharmacy & Healthcare”

This review compares regulations for herbal hair products' labeling and claim validation across various regions, identifying existing discrepancies and discussing the need for global standardization to improve consumer protection and trade facilitation.

research A microscopy-based small molecule screen in primary neurons reveals neuroprotective properties of the FDA-approved anti-viral drug Elvitegravir

3 citations , September 2020 in “Molecular Brain”

This study reports that Elvitegravir, a drug currently approved for other uses, shows potential as a neuro- and mitoprotective agent by attenuating mitochondrial damage caused by NMDA receptors in primary mouse cortical neurons.

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