News

AcelRx Pharmaceuticals announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for DSUVIA™ …
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Otsuka Pharmaceutical and Lundbeck announce that patient enrollment has been initiated in two global Phase 3 clinical trials to evaluate brexpiprazole for the treatment of patients with…
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Merz and Teijin Limited announced that they have entered into a strategic license and co-development agreement for the commercialization of Xeomin (incobotulinumtoxinA) for Japan.…
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Sanofi is investing €170 million to expand a vaccine manufacturing site in Val de Reuil, France. The expansion further strengthens Sanofi's position as one of the world's leading…
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Pfizer announced that it is reviewing strategic alternatives for its Consumer Healthcare business. A range of options will be considered, including a full or partial separation of the…
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Flexion Therapeutics announced that the U.S. Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension), the first and only…
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Mithra announces that Health Canada has accepted the Marketing Authorization Application for its complex therapeutic Tibelia, the company's tibolone-based product for use in Hormone…
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MilliporeSigma today officially opened its new Life Science Center in Burlington, Massachusetts. The new center serves as a regional hub for scientific advancement and customer…
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BioTime reported that an investigator-led clinical trial has successfully treated its first patient in a study of Premvia as a carrier for stromal vascular fraction cells (SVF) for the…
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Izun Pharmaceuticals Corporation announced that the results from a recently completed double blind, Phase 2 clinical study in oral mucositis indicated promising positive outcomes for…
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Titan Pharmaceuticals announced that the first patient has been treated in a Phase 1/2 trial of the company's ropinirole implant intended for the treatment of the signs and symptoms of…
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Janssen Biotech announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral…
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Developing new drugs to treat cancer can be a painstaking process taking over a decade from start to Food and Drug Administration approval. Scientists are trying to develop innovative…
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Kaleido Biosciences announced an agreement with CoreBiome, a genomics platform company focused on accelerating microbiome innovation with expert genomics and big-data analytics, to…
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Boston Biomedical announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for DSP-7888, an investigational cancer peptide vaccine, for the…
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AbbVie announced a research, option and license agreement whereby AbbVie obtained an exclusive option to license up to three of Turnstone's next-generation oncolytic viral…
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Astellas Pharma and Seattle Genetics announced dosing of the first patient in EV-201, a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or…
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Allergan announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ulipristal acetate, an investigational drug for the treatment…
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Ansun BioPharma announced that the Division of Antiviral Products of the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Ansun's first-in-class…
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Boehringer Ingelheim announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and…
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