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GlossaryFDA approval

process ensuring a product's safety and effectiveness for public use

FDA approval is the process by which the U.S. Food and Drug Administration (FDA) formally evaluates and authorizes a product, such as a medication or medical device, for public use based on evidence of its safety, efficacy, and quality. This rigorous process involves multiple phases of clinical trials and extensive review of data to ensure that the benefits of the product outweigh any potential risks.

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community Winlevi just got FDA approval, projected to be available early 2021 in the US

in Treatment 43 upvotes 4 years ago

The conversation is about creating a higher concentration of the newly FDA-approved hair loss treatment, Clascoterone (Winlevi), through compounding pharmacies and possibly organizing group purchases. Some users are unfamiliar with Winlevi and are asking for an explanation of the drug.

community will cb-03-01 price be cheaper if it FDA approval

in Treatment 2 upvotes 3 years ago

The conversation discusses the high prices of hair loss treatments, specifically cb-03-01 and KY19382. It also mentions the use of Minoxidil, finasteride, and RU58841.

community FDA approves Cassiopea's WINLEVI (CB-03-01, 1% formulation) for Acne

in Technology 33 upvotes 4 years ago

The conversation is about the FDA approval of WINLEVI for acne treatment and the anticipation of Breezula, a hair loss treatment using the same active ingredient, which may indicate a positive future for Breezula's release. There is disappointment that Breezula's results are not optimal, but it is seen as progress in hair loss treatment.

community Dermatologist denied prescribing oral dutasteride because it’s not FDA approved BUT did prescribe ORAL minoxidil 😂

in Finasteride/Dutasteride 31 upvotes 5 months ago

A 22-year-old male has been using oral finasteride for a year with no improvement in hair loss and was denied dutasteride by a dermatologist due to FDA approval issues but was prescribed oral minoxidil instead. The user is seeking advice on whether to switch to dutasteride, continue finasteride, or add minoxidil.

community Why does it seem everyone favors finasteride over dutasteride?

in Female 62 upvotes 7 months ago

The conversation discusses preferences for hair loss treatments, specifically finasteride over dutasteride. Users share personal experiences, cost considerations, FDA approval status, and potential side effects, with some switching between treatments to find what works best for them.

community What would hair loss treatment be like in the 2030s?

in Treatment 5 upvotes 5 months ago

The conversation discusses future hair loss treatments, with mentions of dutasteride potentially gaining FDA approval and increased popularity. Skepticism remains about significant advancements due to limited funding and reliance on cosmetic companies.

community This subreddit is 250K members strong, and only 95 likes for this game-changing Verteporfin research? It's pitiful. We need to be encouraging and supportive to any hair transplant surgeon willing to do research on Verteporfin! Go like the video, leave an encouraging comment, and spread this video

in Research/Science 108 upvotes 5 months ago

The conversation discusses the need for more support and awareness for Verteporfin research in hair loss treatment, emphasizing its potential benefits and quick implementation due to existing FDA approval. Users express skepticism due to past scams but acknowledge the importance of encouraging doctors to conduct trials.

community Don’t trust everything y’all are hearing about Pyrilutamide

in Research/Science 10 upvotes 1 year ago

The conversation warns about taking information on pyrilutamide with skepticism, suggesting that many may not have the genuine product. It advises to wait for FDA approval for reliable information.

community Does Fluridil even work? (Eucapil)

in Treatment 6 upvotes 3 years ago

Hair loss discussion includes treatments like Minoxidil, Finasteride, and RU58841. Eucapil's effectiveness is questioned due to unconvincing clinical trial and lack of FDA approval.

community Quick rant about fin/dut posts on this sub.

in Finasteride/Dutasteride 175 upvotes 4 years ago

Hair loss treatments Finasteride and Dutasteride are discussed, with emphasis on their safety and effectiveness. Users share frustration about fear-mongering and side effect discussions, suggesting trust in scientific studies and FDA approval.

community When will Breezula, SM04554, Follica FOL-004, follicum FOL-005 arrive in Canada?

in Question 8 upvotes 4 years ago

The conversation is about the availability of hair loss treatments Breezula, SM04554, Follica FOL-004, and Follicum FOL-005 in Canada after FDA approval, including potential delays, loopholes for obtaining them, and insurance coverage.

community If RU58841 is such an effective anti androgen

in Research/Science 46 upvotes 11 months ago

RU58841 is discussed as a topical anti-androgen for hair loss, but its effectiveness and safety are not well-documented, leading to mixed opinions and experiences among users. Some combine it with finasteride, but concerns about side effects and lack of FDA approval limit its popularity.

community Is Pyri worth it at the moment?

in Chat 26 upvotes 1 year ago

The conversation is about the effectiveness and safety of a hair loss treatment called Pyri, with users discussing its availability and comparing it to other treatments like RU58841, fluridil, and alfatradiol. Some users are waiting for FDA approval before using Pyri, while others share their positive experiences with RU58841 and suggest additional treatments with minimal side effects.

community Anyone familiar with Exosome Therapy from Springs Rejuvenation?

in Treatment 1 upvotes 3 months ago

A user is considering exosome therapy from Springs Rejuvenation for hair loss after unsuccessful attempts with PRP, adipose injections, and a laser cap. They are intrigued by the therapy's potential and the clinic's guarantee of 30% improved coverage, despite concerns about FDA approval and high-pressure sales tactics.

community My experience with Pyrilutamide

in Update 3 upvotes 9 months ago

The user experienced a slight decrease in hair shedding and scalp itch, and reduced sebum production using Pyrilutamide, but stopped due to chest pain, breathing difficulties, and heart issues. They felt normal a week after discontinuing and doubted FDA approval for the drug.

community Silicon Valley backed company aims to cure hair loss

in Technology 51 upvotes 2 years ago

A Silicon Valley-backed company aims to cure hair loss. Exciting advancements include mRNA therapies, gene editing, hair cloning, AR degraders, anti-androgens, cell-based rejuvenation, and AI-based drug discovery, with hopes for FDA approval of GT20029 within 10 years.

community Anyone remember Breezula, the promising hairloss drug that was perpetually 3 years away? Well, it's available right now as an acme treatment. Can we just directly apply to the scalp?

in Treatment 43 upvotes 3 years ago

The conversation discusses the availability of Breezula, a drug for hair loss, now being sold as an acne treatment, and whether it can be applied to the scalp. Users express skepticism about new hair loss treatments and suggest waiting for FDA approval.

community Why are there no FDA approved NSAA's yet?

in Research/Science 7 months ago

The conversation discusses why there are no FDA-approved NSAAs like RU58841 on the market, despite their potential superiority to 5AR inhibitors like finasteride. It explores the effectiveness of treatments like Minoxidil, finasteride, and RU58841 for hair loss.

community Will we be able to acquire pyrilutamide when it is on the market in China?

in Research/Science 9 upvotes 1 year ago

The conversation is about the possibility of obtaining Pyrilutamide, a hair loss treatment, once it becomes available in China, despite it not being approved by the US FDA yet. The user wants to use Pyrilutamide along with other treatments.

community Why is dutasteride approved for hair loss in Japan and South Korea but not for USA?

in Research/Science 34 upvotes 2 years ago

The reasoning for GSK's approval of dutasteride for hair loss in Japan and South Korea but not the US, with alternatives such as finasteride, minoxidil and RU58841 mentioned.

community Why are more people not using RU58841

in Product 14 upvotes 8 months ago

People are not using RU58841 for hair loss because it's not FDA approved, lacks long-term safety data, and is difficult to obtain and verify. They prefer FDA-approved treatments like minoxidil, finasteride, ketoconazole shampoo, and microneedling.

community Clascoterone (Winlevi) now approved in Canada

in Product 14 upvotes 1 year ago

The conversation is about the approval of Clascoterone (Winlevi) in Canada for hair loss treatment. One user expressed skepticism about its effectiveness due to low concentration.

community No, Finasteride as a treatment for MPB was not an "accident"

in Research/Science 105 upvotes 3 years ago

Finasteride was intentionally developed to treat BPH and later approved for male pattern baldness (MPB) due to its 5AR inhibition effects. The delay in MPB approval was due to concerns about off-label use for female hirsutism and the prioritization of treating a more debilitating condition.

community So we’re just ok with taking a research chemical now?

in Treatment 179 upvotes 3 years ago

The conversation discusses the use of RU58841, a non-FDA approved research chemical for hair loss, with mixed opinions on its safety and effectiveness. Some users are willing to try it as a last resort after other treatments like Minoxidil and Finasteride failed, while others express concerns about potential long-term side effects and lack of official research.

community Recent Study finds Laser caps are more effective than 5% minoxidil for AGA

in Research/Science 124 upvotes 9 months ago

Laser caps are found to be more effective than 5% minoxidil for treating hair loss, and when combined with minoxidil, they are even more effective. Some users report positive results with laser treatments, while others see no change; the devices are FDA approved, but opinions on their efficacy vary.

community What ever happened to pyrilutamide?

in Technology 47 upvotes 1 year ago

Pyrilutamide, a potentially effective hair loss treatment; other topical treatments like RU58841 and CB-03-01 that may have fewer side effects than Pyrilutamide; and the Phase 3 clinical trials of Pyrilutamide, which is likely to be approved by the FDA soon.

community Likelihood of new treatments in the next few years?

10 upvotes 9 years ago

New hair loss treatments like Shiseido/Replicel and Histogen were discussed, with cautious optimism about their availability by 2018. Setipiprant, Replicel, and Bimatoprost were mentioned as potential treatments expected around 2016-2017.

community What do you think will be the next "big innovation" regarding AGA?

in Research/Science 11 upvotes 6 months ago

The conversation discusses potential new treatments for androgenetic alopecia (AGA), including verteporfin, pyrilutamide, and hair cloning. There is optimism about scientific advancements providing alternatives to minoxidil and finasteride.

community Is there a topical androgen receptor blocker so we don't have to fuck with the enzyme and destroy our allopregnanolone, but go and hit the end target straight?

in Treatment 47 upvotes 7 months ago

The conversation discusses topical androgen receptor blockers for hair loss, mentioning Clascoterone, Pyrilutamide, GT20029, and RU58841. Ketoconazole's effectiveness and application methods are also debated.

community Light therapy helps hair growth (Studies included)

in Research/Science 23 upvotes 8 months ago

Red light therapy is scientifically proven to promote hair growth by increasing strand density and thickness, and it's an additional treatment to DHT blockers like minoxidil and finasteride. Some users are skeptical about the cost and effectiveness of commercial devices, despite studies showing benefits.