A comprehensive view of New Drug / Biologic License Application (NDA / BLA). This page highlights a small sample of our full coverage.
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Recent Articles

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AbbVie reports FDA has requested further information on subcutaneous pump used in its ABBV-951 combination therapy to treat Parkinson’s disease; treatment uses foscarbidopa and foslevodopa along with pump device

FDA advisory committee meeting April 28 to discuss AstraZeneca and Merck’s supplemental NDA for Lynparza in combination with abiraterone and prednisone or prednisolone; combo intended to treat metastatic castration-resistant prostate cancer

Janssen submits NDA to the US FDA seeking approval of niraparib and abiraterone acetate dual-action tablet, plus prednisone, as a first-line targeted treatment for patients with BRCA-positive metastatic castration-resistant prostate cancer

FDA accepts Bristol Myers Squibb’s supplemental biologics license application and European Medicines Agency validates application for Opdivo nivolumab; drug is adjuvant treatment for patients with completely resected stage IIB or IIC melanoma

Pfizer, BioNTech submit sBLA for US FDA approval of Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as primary series or booster for ages 12 years and older

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