Delivers up-to-date industry news on topics like drug approvals, product recalls, company expansions and acquisitions, market trends for all OSD forms, as well as excipients, packaging and supply chain issues. Monitors market trends in specific drug categories as well as in supplements/nutraceuticals. Provides updates on clinical trials. Includes alerts about new or upcoming regulatory issues.
Already approved in alopecia, once-daily Litfulo improved facial and body vitiligo.
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The new CNS powerhouse offers 11 marketed drugs and projects $2.2B in annual revenue.
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The approval marks the first and only OTC, fixed-dose combo of acetaminophen and naproxen sodium.
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A phase 1/2 study showed promising results in treating patients with advanced solid tumors.
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If approved, gildeuretinol will be the first FDA-approved therapy for the inherited retinal disease.
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The oral orexin receptor 2 agonist treats the orexin deficiency that leads to NT1.
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The deal will give the company a potential first-in-class oral drug for rare form epilepsy.
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The experimental small molecule failed to meet the key activity endpoint in a phase 2a trial.
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Zenbexus marks the arrival of a new treatment class.
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If approved, DT120 ODT could offer a treatment option that works through an entirely different mechanism than anything currently used in clinical practice.
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The first of its kind for hypophosphastasia, the orally-active drug is currently undergoing a phase 1/2a trial.
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If confirmed by the Senate, the White House domestic policy aide would replace former FDA chief Marty Makary.
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If approved, the drug will be the first new treatment for pediatric patients with Tourette syndrome in 10 years.
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The drug is currently only available through private healthcare and not via the publicly-funded NHS.
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Just weeks after getting the FDA green light, Japan’s Ministry of Health, Labor and Welfare has approved Takeda’s Ozeful tablets.
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