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Food and Drug Administration (FDA)

Contract development and manufacturing organisation (CDMO) Bora, which specialises in modified release (MR) and solvent production, has reported a successful FDA general inspection for its facility in Zhunan, Taiwan. Read more

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New technologies such as artificial intelligence (AI) could revolutionise pharmaceutical manufacturing but only if regulators change to prevent hindering future innovation. Read more

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In a surprise announcement, pharma company Biogen has revealed it is set to pursue FDA approval for its Alzheimer’s drug aducanumab, which was previously discontinued in March earlier this year. Read more

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Noven Pharmaceuticals, has received approval from the Food and Drug Administration (FDA) for Secuado (asenapine) transdermal system, a transdermal patch formulation for the treatment of adults with schizophrenia. Read more

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OraSure Technologies has seen its OraQuick Ebola Rapid Antigen Test approved for use by the Food and Drug Administration (FDA). Read more

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Oliver Leatham, vice president and global head of value and access at Certara, writes about the complex issues that surrounds assigning a value to new drugs. Read more

Opinion

EPM editor Reece Armstrong examines the consequences of faulty data for a well-known pharma company. Read more

Opinion

Pharmaceutical company WuXi STA has announced that its Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou have passed two US FDA inspections. Read more

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BD has responded to warnings from the FDA surrounding risks from drug-coated devices by trying to reassure customers and shareholders. Read more

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Concerning reports about potential mortality rates caused by paclitaxel-coated devices have been raised by the FDA. Read more

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Reece Armstrong examines Scott Gottlieb's legacy on the FDA and what it means for pharmaceutical manufacturers. Read more

Latest Issue

FDA commissioner Scott Gottlieb is to resign in one month to spend more time with his family, he has announced. Read more

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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

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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. Read 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. Read 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. 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

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