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AstraZeneca agrees to buy US FDA Priority Review Voucher from Sobi worldpharmanews
August 26, 2019
AstraZeneca announced that it has agreed to buy a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) for a total cash consideration of $95m from a subsidiary of...
Boston Scientific announces FDA approval Of ImageReady MRI biospectrumasia
August 25, 2019
Boston Scientific Announces FDA Approval Of ImageReady™ MRI For Vercise Gevia™ Deep Brain Stimulation System
FDA and EMA align on 90 percent of marketing authorisation decisions europeanpharmaceuticalreview
August 23, 2019
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
OTC drug manufacturer receives warning letter for data integrity issues europeanpharmaceuticalreview
August 23, 2019
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
FDA Grants Astellas/Pfizer’s XTANDI® Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer americanpharmaceuticalreview
August 23, 2019
Astellas Pharma Inc. and Pfizer Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) to ...
FDA Grants BeiGene’s Lymphoma Treatment Priority Review americanpharmaceuticalreview
August 23, 2019
BeiGene, Ltd. has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for zanubrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Investigational Zika vaccine receives Fast Track designation europeanpharmaceuticalreview
August 22, 2019
An investigational Zika vaccine currently being evaluated in a Phase I study has been given a Fast Track designation by the FDA.
Sarepta fails to receive FDA approval for DMD drug golodirsen pharmaceutical-technology
August 22, 2019
The US Food and Drug Administration (FDA) has rejected the new drug application (NDA) submitted by Sarepta Therapeutics for accelerated approval of golodirsen to treat certain Duchenne muscular dystrophy (DMD) patients.
Eiger Receives FDA Breakthrough Therapy Designation for Treatment of Hepatitis Delta Virus Infection americanpharmaceuticalreview
August 22, 2019
Eiger BioPharmaceuticals has announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for peginterferon lambda (Lambda) for the treatment of hepatitis delta virus (HDV) infection.
FDA Approves Antibiotic for Community-Acquired Pneumonia contractpharma
August 22, 2019
Patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin with or without linezolid.

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