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).
FDA warns two Chinese drug manufacturers for good practice violations
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Taiwanese biopharma gains orphan drug designation from FDA
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 voluntarily implements corrective action plan for non-child-resistant packs in US
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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The top five tweets: From recalls to orphan drugs — what made EPM readers ‘click’ this week?
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 to expand services as a result of successful FDA Establishment Identifier registration
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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FDA approves first drug to treat smallpox in efforts to thwart bioterrorism
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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FDA issues warning about fake letters that may be linked to extortion scam
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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FDA grants orphan drug designation to treatment of progressive supranuclear palsy
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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FDA grants breakthrough therapy designation to Tecentriq in combination with Avastin
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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The top five tweets: From innovation arms race to smallpox — what enlightened EPM readers this week?
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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FDA action plan on biosimilars is another positive move towards affordable medicines, says GlobalData
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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FDA approves radiotherapeutic for treatment of ultra-rare adrenal gland tumours
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 emphasizes importance of using products that comply with regulations
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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FDA approves first RNA-based therapy for treatment of rare hereditary disease
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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FDA grants accelerated approval for new oral treatment for Fabry disease
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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FDA accepts new drug application for iclaprim
Clinical-stage biopharmaceutical company, Motif Bio, has received acceptance from the US Food and Drug Administration (FDA) for the filing of its new drug application (NDA) for iclaprim to treat acute bacterial skin and skin structure infections
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The top five tweets: From OBN Awards to biologics — what did EPM readers enjoy this week?
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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Biopharma’s acute myeloid leukaemia treatment gains orphan drug designation
Clinical-stage biopharmaceutical company, ASLAN Pharmaceuticals, has been granted orphan drug designation (ODD) for its treatment for acute myeloid leukaemia (AML) — ASLAN003 — by the US Food and Drug Administration (FDA).
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FDA approves first generic version of epinephrine auto-injector
The US Food and Drug Administration (FDA) has approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions.
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Regeneron’s supplemental biologics licence application for EYLEA gains FDA approval
The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals for a supplemental biologics licence application (sBLA) for EYLEA (aflibercept) injection in patients with wet age-related macular degeneration (AMD).
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