research Drug pipeline 2Q22 — a downturn in approvals
This report highlights Amvuttra's approval for hATTR amyloidosis as a more convenient RNAi therapy, and Olumiant's attention as the first systemic drug for hair loss among recent developments.
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5 / 1000+ resultsresearch FDA declines approval of testosterone drug for third time
This report discusses the FDA's third denial of approval for Aveed, a long-acting testosterone injection by Endo Pharmaceuticals, citing continued safety concerns including severe side effects.
research FDA declines approval of testosterone drug for third time
This report discusses the FDA's rejection of Aveed, a long-acting testosterone injection, due to safety concerns despite divided advisory committee opinions, without presenting new clinical data.
research FDA approves Pfizer's JAK inhibitor for adolescents with alopecia areata hair loss
The FDA approved a new Pfizer drug for hair loss in teens.
research DRUG NEWS
The FDA approved a new breast cancer treatment, found flu shots may reduce heart risks, questioned the safety of fast-tracked drug approvals, showed statins don't help with certain pneumonia, and approved a new dementia imaging agent.
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5 / 1000+ resultscommunity 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?
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 FDA Policy Shift Explained: What It Actually Means for PP405, VDPHL-01, Breezula and Hair Loss Drug Timelines
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 Pelage are going to do two phase 3 trials for PP405. How long will it take to complete two phase 3 trials?
Pelage plans to conduct two Phase 3 trials for PP405, a new hair loss treatment, which may take about a year to complete. Users discuss various hair loss treatments, including pyrilutamide, minoxidil, finasteride, and clascoterone, with some expressing impatience over the lengthy trial process compared to faster drug approvals like the COVID vaccine.
community NYT article from 1985 on minoxidil, "wonder drug"
Minoxidil was used as a hair treatment by crushing hypertension tablets and mixing them with other ingredients. It was noted to thicken existing hair more than promoting new hair growth.
community Drug restored full hair in 23% and over 80% of hair in 55% in 6 months
An arthritis drug restored significant hair in people with alopecia areata, but it is not effective for male pattern baldness. The drug, Upadacitinib, has serious side effects and is expensive.
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6 / 801 results- Do I need a prescription to take cyproterone? Cyproterone acetate is a prescription-only medicine in every country that licenses it, and it has no FDA approval in the United States — regulators require a prescriber because the drug needs hormonal and liver monitoring and carries a dose-related meningioma risk flagged by the EMA in 2020.
- Baricitinib: How did a drug for arthritis end up helping people regrow hair from alopecia areata? Baricitinib helps regrow hair by targeting the autoimmune response in alopecia areata.
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Heavy duty finasteride that comes with higher risks
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signaling protein that, when suppressed, may grow hair by reducing inflammation and stem cell loss
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