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- India tightens penalties for submitting false regulatory documentsThe Indian government has introduced stricter penalties for applicants who submit misleading, fake, or fabricated documents to regulatory authorities, prohibiting them from making further filing re…
- Scholar Rock removes Indiana manufacturing site from SMA drug application after FDA cites deficienciesScholar Rock, a Massachusetts biotech, announced it is withdrawing an Indiana manufacturing facility from its filing for a prospective spinal muscular atrophy (SMA) therapy. The decision follows a…