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Company sues FDA over rejecting opioids intended to deter abuse europeanpharmaceuticalreview
September 20, 2019
Pharmaceutical Manufacturing Research Services has filed a lawsuit against the FDA after it rejected its application for opioids with updated labelling and appearance, meant to discourage misuse.
FDA accepts Biologics License Application for V920 Ebola vaccine europeanpharmaceuticalreview
September 20, 2019
A Biologics License Application and priority review has been approved by the FDA for an investigational Ebola vaccine.
FDA Grants Accelerated Approval for Pembrolizumab plus Lenvatinib americanpharmaceuticalreview
September 19, 2019
The Food and Drug Administration (FDA) granted accelerated approval to the combination of pembrolizumab (KEYTRUDA, Merck) plus lenvatinib (LENVIMA, Eisai) for the treatment of patients with ...
FDA Grants Fast Track Designation for Meniere's Disease Treatment americanpharmaceuticalreview
September 19, 2019
Sound Pharmaceuticals announced the FDA's Division of Neurology Products has approved its request for Fast Track Designation (FTD) involving SPI-1005 in the treatment of Meniere's Disease (MD).
Collaborative oncology drugs review initiative announced by FDA europeanpharmaceuticalreview
September 19, 2019
A new initiative has already collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in three countries.
3P Biopharmaceuticals Receives FDA approval contractpharma
September 19, 2019
3P Biopharmaceuticals is a contract development and manufacturing organization (CDMO) specializing in biologic process development and GMP manufacturing.
FDA grants priority review for Merck’s Ebola Vaccine biospectrumasia
September 18, 2019
The Prescription Drug User Fee Act (PDUFA), or target action date, is set for March 14, 2020. In July 2016, the FDA granted Breakthrough Therapy Designation to V920.
AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval biospectrumasia
September 18, 2019
The pivotal studies leading to the RECELL System’s FDA premarket approval (PMA) for the treatment of acute thermal burns demonstrated that the RECELL System treated burns using 97.5 percent less donor skin when used alone in second-degree burns, and 32 pe
FDA Grants Breakthrough Therapy Designation for Genentech’s Gazyva (Obinutuzumab) biospectrumasia
September 18, 2019
Genentech is committed to addressing barriers to clinical trial participation and advancing inclusive research to create new standards for clinical studies.
Janssen Submits TREMFYA Application to FDA for Psoriatic Arthritis americanpharmaceuticalreview
September 18, 2019
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking ...

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