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.
The facility will focus on manufacturing APIs for solid dosage tablets and capsules as part of a plan to produce all key medicines within the country.
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The drugs include metformin, metformin extended release, Invokana (an SGLT2 inhibitor for type 2 diabetes) and blockbuster Xarelto (a blood thinner).
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Ajax's lead candidate is an oral, Type II JAK2 inhibitor that uses a unique mode of binding for potentially deeper and more durable disease control.
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Idvynso demonstrated non-inferior efficacy compared to the three-drug regimen in a phase 3 trial.
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If approved, the drug will be the first oral GLP-1 RA that provides superior glycemic efficacy in pediatric patients with T2 diabetes.
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Three psychedelic drugs will receive national priority vouchers from the FDA next week.
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The phase 1 trial led to median hsCRP reductions of more than 85% when patients took daily doses.
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Among its most promising drugs is oral ribupatide, a once-daily pill entering phase 3 trials in China.
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Schwartz, an ex deputy surgeon general, will take over the role if she receives Senate approval, which could take months.
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The FDA has granted full approval to Filspari to reduce proteinuria in focal segmental glomerulosclerosis without nephrotic syndrome.
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Dapagliflozin tablets are approved for patients with type 2 diabetes mellitus at risk for cardiovascular disease.
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CDI-988, currently in a phase 1b trial, is the first oral antiviral candidate to treat and prevent norovirus infection.
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Daraxonrasib led to improvements in both progression-free survival and mean overall survival compared to standard of care.
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Brinsupri, the first treatment for non-cystic fibrosis bronchiectasis, was originally approved by the FDA in August 2025.
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The highlight of the $2.9 billion deal is Vykat, the only FDA-approved treatment for hyperphagia in Prader Willi syndrome.
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