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U.S. Food and Drug Administration issued warning letters to 15 companies Including Several In California for illegally selling products containing cannabidiol (CBD) in ways...

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15 Companies received warning letter by U.S. Food and Drug Administration for illegally selling products containing cannabidiol as agency details safety concerns

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Oxbryta (voxelotor) approved by U.S. Food and Drug Administration for the treatment of sickle cell disease (SCD)

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The first oral small molecule targeting splicing Risdiplam approved by US FDA for the treatment of spinal muscular atrophy

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Vaccitech announces successful recruitment and vaccination for two phase 2 Universal influenza studies FLU009 and FLU010 for the treatment and prevention of cancer...

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FDA approves new system for the delivery of tympanostomy tubes under local anesthesia to treat ear infection

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Takeda says cancer drug Alunbrig (brigatinib) results in longer benefit vs crizotinib After Two Years of Follow-Up

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Roche presents pivotal First Phase III cancer immunotherapy Tecentriq in combination with Avastin to show an improvement in liver cancer patients

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ViiV Healthcare announces exclusive licensing agreement with NIH to develop investigational bNAb N6LS for treatment & prevention of HIV-1

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BioMarin seeks European marketing Authorization for valoctocogene roxaparvovec to treat severe hemophilia A

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Regulatory Affairs

Medical Device Registration in Japan-Todokede, Ninsho and Shonin Pathways

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Amgen Completes Acquisition Of Otezla® (apremilast) for the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis

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