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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The FDA has granted marketing authorisation for Ofev, as the first treatment for patients with chronic fibrosing interstitial lung diseases (ILDs).
The US agencies have issued letters to seven companies, and removed online listings from others, whose products falsely claim to prevent or treat coronavirus.
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.
European Pharmaceutical Review explores how a surge in the number of warning letters for data integrity failings have prompted regulators to publish new guidelines.
The FDA has approved Isturisa for Cushing’s disease treatment after it demonstrated significant efficacy in clinical trials.
The DURYSTA ocular implant has been approved by the FDA to reduce intraocular pressure in open-angle glaucoma or ocular hypertension.
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.
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
The US FDA will fund a research project using Raman spectroscopy and mass spectrometry to study drug delivery via the skin.
A report has suggested that number of Orphan Drug Designations in both the US and Europe is declining, possibly due to prices and political changes.
The FDA has released a statement, announcing that the US is experiencing its first shortage as a result of the effects of COVID-19.
Advil Dual Action is the first FDA-approved an over-the-counter ibuprofen and acetaminophen combination, backed up with data from several clinical trials proving its efficacy.
Ranitidine tablets have been recalled due to the possibility of the products containing unacceptable levels of NDMA.
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
The FDA and EMA have accepted licence applications for ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS).