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Food and Drug Administration (FDA)

Jennifer Lopez, director, solutions delivery at Maetrics discusses why heightened due diligence is needed for pharmaceutical manufacturers during mergers and acquisitions. Read more

Opinion

Peter Morgan - technical product specialist at Elementar UK - explains how TOC analysers help to deliver reliable results for drug makers, and how new advances are keeping them at the forefront of the quality assurance (QA) process. Read more

Analysis

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. Read more

News

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

News

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. Read more

News

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

News

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. Read 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). Read more

News

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. Read more

News

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). Read more

News

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

News

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. Read 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). Read more

News

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. Read more

News

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

News