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 new program will give companies that test and manufacture generics in the U.S. priority review.
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The deal aims to ensure U.S. patients pay lower prices for prescription medicines while strengthening America’s role as the global biopharma leader.
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After becoming the first female CEO of a major pharmaceutical firm, Walmsley will hand over leadership to Luke Miels.
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Currently under priority review, the drug has a November 30, 2025 PDUFA date.
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The Houston plant It will produce Lilly’s new oral GLP-1 if approved.
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Inluriyo treats advanced breast by degrading overactive estrogen receptors in cases of ESR1 mutations.
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A causal relationship has not been established and there are contrary studies in the scientific literature.
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The European Commission is expected to make a final decision about approval in the EU within the next months.
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Additional analyses during the review of tolebrutinib has led the FDA to extend its decision by three months.
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The European Commission has given marketing authorization to Biogen for Zuzuvae.
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The pill is already in the hands of regulators, with a decision pending this year.
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The company has agreement with the agency on the manufacturing, clinical and nonclinical activities required for a future marketing approval of the once-a-day pill, Xanamem.
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The companies have agreed to a collaboration to develop degraders to treat immune-mediated diseases.
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The MHRA has approved Voranigo to treat patients 12 years of age and older with grade 2 astrocytoma or oligodendroglioma.
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The oral drug, approved to treat primary biliary cholangitis, has been flagged by the FDA due to liver injury.
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