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FDA Accepts Regulatory Submission for Tanezumab americanpharmaceuticalreview
March 04, 2020
Pfizer and Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tanezumab 2.5 mg administered subcutaneously (SC) ...
FDA accepts Zejula sNDA application as a maintenance treatment for ovarian cancer europeanpharmaceuticalreview
March 04, 2020
The developers of Zejula (niraparib) have announced the FDA will assess the sNDA application under the Real-Time Oncology Review (RTOR) pilot programme.
FDA and EMA accept licence applications for multiple sclerosis treatment europeanpharmaceuticalreview
March 04, 2020
The FDA and EMA have accepted licence applications for ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS).
Orphan Drug Designations are declining, says market analysis europeanpharmaceuticalreview
March 04, 2020
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.
Raman spectroscopy and mass spectrometry to be used in study of topically applied drugs europeanpharmaceuticalreview
March 04, 2020
The US FDA will fund a research project using Raman spectroscopy and mass spectrometry to study drug delivery via the skin.
FDA approves Esperion’s non-statin LDL-C lowering drug pharmaceutical-technology
March 03, 2020
Esperion has announced the US Food and Drug Administration (FDA) has approved Nexlizet (bempedoic acid and ezetimibe).
FDA sends warning letter to KVK-Tech manufacturing facility europeanpharmaceuticalreview
March 03, 2020
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.
FDA approves Advil Dual Action for over-the-counter pain relief europeanpharmaceuticalreview
March 03, 2020
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.
Orphan drugs face uphill battle in 2020: GlobalData expresspharma
March 03, 2020
ODDs have been a focus of interest from the pharma industry for many years, with many companies enticed by the benefits of the enhanced regulatory processes, tax benefits and extended market exclusivity.
US FDA approves first generic version of $750 Daraprim drug expresspharma
March 03, 2020
The drug is used to treat toxoplasmosis, a disease that causes flu-like symptoms and occurs usually by eating undercooked contaminated meat.

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