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Anti-malarial drugs donated to aid fight against COVID-19
The producers of hydroxychloroquine have stated they will donate 130 million doses if the drug is approved as a treatment for the COVID-19 coronavirus.
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US Food and Drug Administration (FDA)
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Study evaluates if siltuximab benefits COVID-19 patients with respiratory complications
The SISCO study will assess if the anti-IL-6 antibody siltuximab can aid patients suffering Acute Respiratory Distress Syndrome as a complication of the COVID-19 coronavirus.
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FDA approves label update to sodium glucose co-transporter-2 (SGLT2) inhibitors
Safety updates to labels of SGLT2 inhibitors will recommend temporary discontinuation of these medications before scheduled surgery, says the FDA.
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Olumiant (baricitinib) granted Breakthrough Therapy designation by FDA
Baricitinib has been granted Breakthrough Therapy as a treatment for alopecia areata, an autoimmune condition with no FDA-approved therapies.
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Fast Track designation granted to chronic kidney disease treatment
The US FDA has granted Fast Track designation to Jardiance® for the treatment of chronic kidney disease.
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Hikma Pharmaceuticals extends Ketorolac Tromethamine recall in US
The FDA has announced that Hikma are now recalling certain lots of Ketorolac Tromethamine injections at the medical facility and retail levels.
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Ofev® (nintedanib) approved by FDA to treat interstitial lung diseases
The FDA has granted marketing authorisation for Ofev, as the first treatment for patients with chronic fibrosing interstitial lung diseases (ILDs).
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FDA and FTC issue warning letters to companies selling fraudulent COVID-19 products
The US agencies have issued letters to seven companies, and removed online listings from others, whose products falsely claim to prevent or treat coronavirus.
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FDA announces changes that will soon affect compounders
A change to the law will soon be impacting compounding of certain products beginning on 23 March 2020 the US Food and Drug Administration (FDA) has announced.
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Exploring data integrity guideline changes moving into 2020
European Pharmaceutical Review explores how a surge in the number of warning letters for data integrity failings have prompted regulators to publish new guidelines.
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FDA approves Isturisa (osilodrostat) treatment for Cushing’s disease
The FDA has approved Isturisa for Cushing’s disease treatment after it demonstrated significant efficacy in clinical trials.
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FDA approves DURYSTA™ (bimatoprost implant) New Drug Application
The DURYSTA ocular implant has been approved by the FDA to reduce intraocular pressure in open-angle glaucoma or ocular hypertension.
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Online pharmacy finds high levels of NDMA in metformin
Tests conducted by an online pharmacy has revealed high levels of NMDA in the diabetes drug metformin, prompting the company to press for a recall.
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EC grants marketing authorisation to Givlaari® (givosiran) for acute hepatic porphyria
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
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Raman spectroscopy and mass spectrometry to be used in study of topically applied drugs
The US FDA will fund a research project using Raman spectroscopy and mass spectrometry to study drug delivery via the skin.
