Press Releases
Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%
Allergan plc announced that the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, has been accepted by the U.S....
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Seqirus receives FDA approval for FLUCELVAX QUADRIVALENT
CSL announced that the US FDA has approved Seqirus’ FLUCELVAX QUADRIVALENT™ (Influenza Vaccine), the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. FLUCELVAX QUADRIVALENT helps protect against the two...
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Rituximab regulatory submission accepted by European Medicines
Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year Sandoz is seeking approval for all indications included in the reference product's label. Sandoz' submission includes data from multiple clinical trials...
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FDA Expands Invokamet Label to Include First-Line Treatment of with type 2 diabetes
Janssen Pharmaceuticals, Inc announced the U.S. FDA has approved INVOKAMET®, a fixed-dose combination therapy of INVOKANA® (canagliflozin) and metformin hydrochloride, for first-line treatment of adults with type 2 diabetes. With this new approval, INVOKAMET® may now...
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Anti-Cancer Agent vastin ,Obtained Approval for Additional Indication of Advanced or Recurrent Cervical Cancer
Chugai Pharmaceutical Co Ltd announced that it gained approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) on May 23, 2016, for “advanced or recurrent cervical cancer,” as new additional indication for the anti-cancer agent / anti-VEGF...
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Astellas Pharma Inc , Daiichi Sankyo, and Takeda Announce Research Collaboration on Establishing Biomarker Database on Healthy Adults
Three Pharmaceutical Companies with Research Bases in Japan Work Together to Accelerate Innovation in Japan-Originated Drug Discovery Astellas Pharma Inc ,Daiichi Sankyo Company, Limited and Takeda Pharmaceutical Company Limited announced that they have entered into a...
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Boehringer Ingelheim and BioMed X start new project to explore and develop unprecedented new treatment approaches for psychiatric diseases applying crowdsourcing
Aims to identify maladaptive brain circuits to find new approaches for treating psychiatric diseases Second Boehringer Ingelheim crowdsourcing project with BioMed X builds on success of previous project focused on epigenetic drivers of COPD New research team...
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