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
Published: March 23, 2023 by FiercePharma
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
Published: March 02, 2023 by Alliance News
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
Published: March 01, 2023 by Johnson & Johnson Services Inc.
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
Published: February 28, 2023 by Bristol-Myers Squibb Co.
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
Published: February 27, 2023 by PharmaBiz (India)

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