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Food and Drug Administration (FDA)

The US Food and Drug Administration (FDA) has accepted a supplemental biologics licence application (sBLA) for Praluent (alirocumab) injection as a potential treatment to reduce major adverse cardiovascular events. more

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The US Food and Drug Administration (FDA) has approved new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence. more

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The US Food and Drug Administration (FDA) has issued warnings to four more online networks (operating a total of 21 websites) concerning the illegal marketing of potentially dangerous, unapproved and misbranded versions of opioid medications. more

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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. more

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Allergan has disclosed that it has received a complete response letter (CRL) from the US Food and Drug Administration indicating that it cannot approve the new drug application (NDA) submitted for ulipristal acetate. more

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Commercial stage biotechnology acceleration development company, Q BioMed, with licensor of Strontium 89 Chloride, BioNucleonics, have announced the submission of a supplemental regulatory filing for a new manufacturing facility. more

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The US Food and Drug Administration (FDA) has approved the first drug — Oxervate (cenegermin) to Dompé farmaceutici SpA — for neurotrophic keratitis, which is a rare eye disease that affects the cornea. more

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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). more

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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. more

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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). more

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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. more

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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 more

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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. more

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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. more

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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. more

Opinion

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). more

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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. more

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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. more

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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 more

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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. more

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