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.
Issues with opening the pouch and film placement could be dangerous for patients suffering from anaphylaxis.
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The trial is the first phase 3 study of a Factor XIa inhibitor which demonstrated superiority in reducing recurrent ischemic stroke.
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Ireland-based ProSys will continue to operate as an independent business.
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Per the FDA, Translarna does not meet the threshold of evidence of effectiveness and is unlikely to receive approval.
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The action removes risk statements related to cardiovascular disease, breast cancer and probable dementia.
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Based on the data, Compass has submitted a request for a meeting with the FDA to discuss a rolling submission and review.
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The drug saw positive results in a previous study, reducing symptoms and the duration of illness in COPD patients with a rhinovirus infection.
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The expansion will create one of the top three pharmaceutical GCCs in India.
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The FDA says it needs to see the results of the phase 3 Apollo study, which is currently in progress, before it is able to come to a decision.
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Bysanti, an atypical antipsychotic, is expected to become commercially available in Q3 2026.
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Novo Nordisk brings to the deal its expertise in peptide and protein therapeutics, whereas Vivtex will be licensing its oral drug-delivery technologies.
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The company observed reversible cardiac issues in healthy volunteers who were taking above target therapeutic doses.
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The company will use the investment to turn Ireland into a hub for producing high-quality oral medications to distribute outside the U.S.
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If approved, DOR/ISL may provide an important new option to help meet the evolving treatment needs of people living with HIV.
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Results are comparable to another phase 3 trial, solidifying the oral drug’s potential to become the first BTK inhibitor for relapsing multiple sclerosis.
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