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    The US Food and Drug Administration (FDA) has issued warnings to two Chinese drug manufacturers for violations of good manufacturing practice (GMP), according to a post from the Regulatory Affairs Professionals Society (RAPS).

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    Taiwanese biopharma company, OBI Pharma, has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for its treatment of hepatocellular carcinoma (HCC), OBI-3424.

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    Novartis Pharmaceuticals, in cooperation with the US Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA), has voluntarily implemented a corrective action plan concerning Zofran and Entresto packages in the US.

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    Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics.

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    Concept Life Sciences — integrated drug discovery, development and analytical services company — has achieved FDA Establishment Identifier (FEI) registration and commissioned an expansion of its services as a result.

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    The US Food and Drug Administration (FDA) has approved the first drug indicated to treat smallpox — TPOXX (tecovirimat) — to SIGA Technologies.

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    The US Food and Drug Administration (FDA) has issued a warning to consumers about criminals who are forging warning letters, as though they have been written by the agency, in efforts to target individuals who are trying to purchase medicines online

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    The US Food and Drug Administration (FDA) has granted orphan drug designation to Asceneuron’s treatment of progressive supranuclear palsy (PSP) — which is a rapidly progressing rare neurodegenerative disorder.

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    The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Roche’s Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as a first-line treatment for people with advanced or metastatic HCC

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    Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics.

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    The recently announced ‘Biosimilar Action Plan’ (BAP) from the US Food and Drug Administration (FDA) is another move by the regulatory body to achieve cost-effective pricing, according to an analyst at data and analytics company, GlobalData.

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    An intravenous injection — Azedra (iobenguane I 131) — for the treatment of adults and adolescents age 12 and older with rare tumours of the adrenal gland that are unresectable, has been approved by the US Food and Drug Administration (FDA).

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    Aflex Hose — a business division of Watson-Marlow Fluid Technology Group — has emphasized the importance of using products that are within the rules and comply with regulatory bodies’ specifications.

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    The US Food and Drug Administration (FDA) has approved the first RNA-based therapy for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

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    The US Food and Drug Administration (FDA) has granted accelerated approval for a new treatment for adults with Fabry disease — a rare genetic disorder, resulting from the build-up of globotriaoscylceramide (GL-3) in blood vessels and organs.

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