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Immuno-Oncology News 07/23/2019 14:58
The U.S. Food and Drug Administration (FDA) has approved three clinical studies testing PrimeVax Immuno-Oncology’s investigational approach using dendritic cells and dengue virus for cancer treatment. The investigational new drug (IND) application is for patients with melanoma (skin cancer) who have failed prior immune checkpoint inhibitors. Hospital sites are being prepared to start dosing patients […]. .
Healio News 07/23/2019 14:55
FDA approves Recarbrio for complicated UTIs, pharmacist-delivered therapy produces high sustained viral response rates.
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Merck has secured approval from the US Food and Drug Administration (FDA) for its Recarbrio (imipenem, cilastatin and relebactam) to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI.
More from Pharmaceutical Business Review: 07/17/2019 17:07
Relebactam received FDA’s Qualified Infectious Disease Product (QIDP) designation for the treatment of cUTI and cIAI.
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GlobeNewswire 07/17/2019 08:15
In her presentation, Dr. Mounts recommended several ways in which the LPAD draft guidance for industry issued by FDA could be strengthened, and emphasized the public health importance of the LPAD pathway for novel antimicrobial products such as Neutrolin.
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PR Newswire 07/10/2019 13:35
An independent laboratory study shows that DuraDerm®, an FDA-cleared microbicidal liquid polymer, kills 99.99 percent of the C. auris fungus on contact.
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The FDA granted priority review status based on the previous Qualified Infectious Disease Product (QIDP) designation, which provides certain incentives for the development of antibacterial and antifungal treatments for serious or life-threatening infections.
More from RT: For Decision Makers in Respiratory Care:
Becker's Hospital Review 06/14/2019 09:58
Patient dies from fecal transplant, FDA warns.
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Business Wire 06/12/2019 12:06
SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode will have access to higher volume laboratories that utilize the Roche MagNA Pure 96 system for sample extraction.
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Benzinga 06/10/2019 09:00
Novavax, Inc. (NASDAQ: NVAX ), which develops vaccines for infectious diseases, announced updates on its licensure for ResVax. The U.S. Food & Drug Administration has recommend the company conduct an additional Phase 3 trial. What To Know. ResVax is a late-stage study of Novavax's respiratory syncytial virus vaccine and has failed to hit its main goal. Novavax has held meetings with several European national regulatory agencies to solicit input on the prepare trial and ... Full story available on

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