In a first, FDA approves topical rare disease drug
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Today's Rundown

Featured Story

Physician poll finds ultralong-acting regimens and home administration could transform HIV market

Ultralong-acting regimens and home administration could rapidly shift the HIV market away from daily orals as the sector enters its “last cycle of innovation,” according to physicians surveyed by analysts at Jefferies.

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Top Stories

Oral prolonged-release ketamine advances after COVID-disrupted trial

HMNC Brain Health and Develco Pharma are forging ahead with development of oral prolonged-release ketamine after seeing a “positive trend” in treatment-resistant depression, with a midphase study slated to start in the second quarter.

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In a first, FDA approves topical sirolimus for rare disease lesions

Nobelpharma America has become the first company to win FDA approval for a topical treatment for facial angiofibroma associated with tuberous sclerosis complex (TSC). The approval covers a topical gel formulation of sirolimus, a mTOR inhibitor also known as rapamycin.

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Genprex pairs gene therapy delivery tech with Keytruda in lung cancer trial

Genprex has begun testing a drug candidate based on its systemic gene therapy delivery platform in combination with Merck’s Keytruda. The phase 1/2 clinical trial marks the start of Genprex’s effort to determine whether a delivery system based on opposing electrical charges can help improve the efficacy of the checkpoint inhibitor in patients with late-stage non-small cell lung cancer.

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Antares, Lipocine expand testosterone therapy offerings with FDA nod for a new, oral med for hypogonadism

Antares and development partner Lipocine have gained FDA approval for Tlando, an oral testosterone replacement therapy for hypogonadism. The twice-daily oral drug is an alternative to Antares' Xyosted, a weekly injected TRT, which has been on the market for four years.

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