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FDA and DEA send joint warning letters to illegal opioid sites
The FDA and DEA have, for the first time, sent joint warning letters to four networks which were illegally selling opioid products.
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US Food and Drug Administration
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FDA grants Orphan Drug Designation for narcolepsy treatment
The FDA has given the XWL-008 compound Orphan Drug Designation for the treatment of narcolepsy.
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FDA joins blockchain system for drug safety
A multi-company system to improve traceability of pharmaceutical products is newly supported by the FDA.
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Type 2 diabetes treatment approved for children and adolescents
The FDA has approved an injection for use in patients aged 10-17 to treat type 2 diabetes.
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FDA dermatology advisors found to accept payments after drug approvals
A study has shown that the majority of dermatology advisors to the FDA took payments subsequent to drug approvals.
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Proposed biosimilar accepted for review by EMA
The EMA has accepted Prestige BioPharma’s marketing application for its trastuzumab biosimilar.
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Shingles vaccine approved for use in China
GlaxoSmithKline (GSK) has been given Chinese approval for its shingles vaccine.
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FDA approves first gene therapy for paediatric spinal muscular atrophy
The FDA has given approval to AveXis for the first treatment of paediatric spinal muscular atrophy (SMA).
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FDA clarifies activities during US government shutdown
The FDA has clarified what it can and cannot do in light of the ongoing US government shutdown meaning a lapse in funding during the period...
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FDA updates on voluntary valsartan recalls
The FDA has provided guidance on valsartan recalls that have been occuring recently, providing lists of drugs affected, and methods of impurity testing...
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Most FDA required post-marketing drug studies are missing
The FDA requires drugs to be tested on children after they have been approved for adults, however two thirds of these are not happening...
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Taking a collaborative approach to continuous pharmaceutical manufacturing
Offering increased yields, lower utility consumption and reduced waste, continuous manufacturing presents a paradigm shift in drug production and meets the pharmaceutical industry’s demands for faster product development, reduced costs, improved production economics and increased flexibility.
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Geographic distribution of antibiotics after market introduction
Center for Disease Dynamics, Economics & Policy researchers have mapped the geographical distribution of antibiotics after their market introduction...
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FDA piloting innovative clinical trial designs
The US FDA is looking to begin a new phase of innovative clinical trial designs...
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FDA approves first drug for neurotrophic keratitis
The FDA has approved the first treatment for neurotrophic keratitis, which completely healed the rare disease in 70 percent of cases.
