Regulatory
The Christiana Care Health System’s Gene Editing Institute, based in Wilmington, Del., is pulling together a preliminary investigational new drug application (IND) for the U.S. Food and Drug Administration (FDA).
The CRL called for additional CMC and non-clinical information for the post-operative pain treatment. It did not specify any safety or efficacy concerns.
The FDA gave the nod to AbbVie’s Mavyret for all six strains of hepatitis C in children ages 12 to 17 years. The drug was approved for adults 18 years or older in 2017.
Nabriva Therapeutics announced that the Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for Contepo (Fosfomycin) to treat complicated urinary tract infections (cUTI), including acute pyelonephritis.
Gene Editing Institute’s study will be a novel investigation of the use of CRISPR technology to treat K-ras-positive non-small cell lung cancer
Karolinska Development AB has published its Annual Report for 2018.
Following the capital increase and listing on Nasdaq, cash and cash equivalents totaled €314.1 million as of March 31, 2019
NHS England will acquire hepatitis C drugs from the companies at competitive prices and work to identify patients around the country.
BioArctic AB to publish the company’s Interim Report for the period January – March 2019 on Thursday, May 9, 2019 at 08:00 a.m. CET.
The NDA was based on positive Phase III data that shows the once-a-month treatment is as effective as the daily standard of care.
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