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Food and Drug Administration (FDA)

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

News

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

News

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

News

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

News

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

News

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

News

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

News

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

News