BioSpace News Archive

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.

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.

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 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).

Are you fascinated with microbiology? Have you ever thought about how to integrate your passion for research and entrepreneurship? The field of microbiology is expanding and being significantly impacted by advancements in technology.

Eisai Co., Ltd has bought out Purdue Pharma L.P.'s rights in the worldwide collaboration for the development and commercialization of lemborexant, an investigational sleep-wake regulation agent being studied for the treatment of multiple sleep-wake disorders, including insomnia and irregular sleep-wake rhythm disorder (ISWRD) in patients with Alzheimer Disease.

Blythedale Children’s Hospital and Burke Neurological Institute announce the appointment of Dianna E. Willis, Ph.D., as Director of Research for the Burke-Blythedale Pediatric Neuroscience Research Collaboration.

UndergroundStocks.com, an elite wall street independent small cap media group with a history of bringing lucrative opportunities, Reports on Omni Health, Inc.

Recipharm AB will publish its interim report for January-March 2019 on 3 May at 07:45 am CET.

Biom’up announced its full-year results for the year ending December 31, 2018, as approved by the Company’s Board of Directors on April 29, 2019, and provided an update on its operations.