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Akebia submits New Drug Application for Anemia drug in Japan biospectrumasia
July 23, 2019
The JNDA is the first regulatory submission for marketing approval of vadadustat and, if approved, is expected to lead to the first launch of vadadustat worldwide.
Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder drugs
June 12, 2018
Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder (OUD).
AcelRx resubmits New Drug Application for DSUVIA americanpharmaceuticalreview
May 18, 2018
DSUVIA (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, has a proposed indication for the management of moderate-to-severe acute pain in medically supervised settings,
Lupin submits New Drug Application for Etanercept biosimilar in Japan biospectrumasia
May 10, 2018
“After significant investment in our biotechnology R&D division over the years, this is the first biosimilar for regulated markets developed in-house at Lupin and the first ever complex fusion protein like etanercept in regulated markets by an Indian phar
Starpharma completes US New Drug Application for VivaGel BV biospectrumasia
May 02, 2018
VivaGel BV stands to be the first and only product approved for the prevention of recurrent BV
Janssen submits new drug application to FDA for HIV-1 treatment pharmaasia
September 30, 2017
The new drug that Janssen is seeking approval for would be the world’s first darunavir-based single tablet regimen for HIV-1.