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Regulatory

Approvals, filings, CRLs, breakthrough designations and advisory committees.

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321–322 of 322
Aug 5Wed
  1. WeChat79

    Huahai's Huatai Bio Approves Recigenimab for Generalized Pustular Psoriasis in Adults

    On July 29, Huatai Bio's recigenimab was approved in China as the first domestically developed new drug for generalized pustular psoriasis (GPP) in adults. The approval marks the first local launch of a treatment for this rare disease. The drug adds to a series of innovations from Pudong-based companies.

    Why it matters: First domestic approval of a new drug for adult generalized pustular psoriasis, a rare disease.

Aug 4Tue
  1. WeChat82

    FDA Approves Novartis Pluvicto for PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer

    The US FDA has approved Novartis's Pluvicto for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), roughly doubling the eligible patient population. In the PSMAddition study, Pluvicto plus standard of care (ADT plus ARPI) reduced the risk of disease progression or death by 33% versus standard of care alone, with a positive overall survival trend (HR=0.80). About half of men with mHSPC progress within 20 months.

    Why it matters: FDA label expansion for Pluvicto into earlier-line mHSPC nearly doubles its eligible population.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org