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 agency has set a PDUFA target action date of April 30, 2026 for the oral NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor.
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The new nod makes Aqvesme the only FDA-approved drug for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.
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BHV-7000 also fell short in a phase 3 bipolar mania trial back in March.
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An oral drug for lowering LDL cholesterol and a treatment for advanced cancers will have shortened review times.
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The Japan-based company will acquire Radicava ORS and IV Radicava along with a subsidiary in the U.S.
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The deal will give BioMarin Amicus’s lead oral drug, Galafold, approved in 2018 for Fabry disease.
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A single-tablet regimen combining bictegravir and lenacapavir could potentially transform the HIV treatment landscape.
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Augmentin XR received approval after just two months via the CNPV pilot program, marking the first drug to win approval using the new pathway.
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The FDA has delayed its decision about tolebrutinib for a second time and Sanofi will not pursue approval in primary progressive multiple sclerosis.
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The closure will eliminate 91 jobs, with some workers being offered transfers to positions within Roquette.
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The facility is one of nine U.S. manufacturing sites that Lilly has announced since 2020.
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Giredestrant the first SERD to demonstrate superior invasive disease-free survival in early breast cancer, suggesting a new standard of care.
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In a deal that could exceed $2B, Pfizer will pick up YaoPharma’s small molecule GLP-1 receptor agonist currently in trials for chronic weight management.
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In the phase 2b trial, a 120 mg dose led to a mean weight loss of 11.3% and a 240 mg dose to 15.3% at 36 weeks.
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The drug demonstrated efficacy on par with Sanofi and Regeneron's blockbuster drug, Dupixent.
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