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 Delhi High Court has cleared Natco Pharma to launch its generic version of Roche’s spinal muscular atrophy drug.
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The FDA has given Xspray a second CRL for its leukemia drug, this time due to GMP observations related to its third party manufacturer.
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NUZ-001 can now be part of the HEALEY ALS Platform Trial, expected to commence Q4 of this year.
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The FDA has approved a second generic version of mifepristone.
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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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