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New draft guidance promotes diversity in clinical trials
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
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Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
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Ustekinumab could be approved to treat ulcerative colitis
Ustekinumab has been submitted to be the first interleukin (IL)-12/23 inhibitor licensed for the treatment of ulcerative colitis...
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MHRA announces EU exit no-deal legislative proposals
Innovators should be able to get products to the UK market as quickly and simply as possible, according to the Medicines and Healthcare products Regulatory Agency...
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Drug delivery to the heart with tannin acid may avoid surgery
Tannin acid injections to treat cardiovascular disease may avoid the need for surgery, according to research from Korea...
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Mass Spectrometry In-Depth Focus 2018
This In-Depth Focus looks at the benefits of mass spectrometry for the characterisation of protein higher order structure and for stability testing.
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FDA expands approval of Imfinzi to reduce the risk of NSCLC progression
The FDA has approved Imfinzi for the treatment of patients with stage III non-small cell lung cancer whose tumours are not able to be surgically removed and whose cancer has not progressed after treatment...
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FDA accepts IND for the treatment of mucopolysaccharidosis type IIIA
The FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug application for the drug candidate SOBI003...
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FDA approves new indication for Gilotrif in EGFR mutation-positive NSCLC
The FDA has approved a supplemental New Drug Application for Gilotrif for the first-line treatment of patients with metastatic non-small cell lung cancer...
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FDA approves Admelog, the first follow-on insulin product to treat diabetes
The FDA has approved Admelog, a short-acting insulin indicated to improve control in blood sugar levels in diabetes...
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Tudorza reduces exacerbations in COPD patients
AstraZeneca has announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair in patients with moderate to very severe COPD...
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FDA approves Vraylar in the maintenance treatment of schizophrenia
The FDA has approved the supplemental New Drug Application for Vraylarfor the maintenance treatment of adults with schizophrenia...
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FDA approves Zelboraf for certain patients with Erdheim-Chester disease
The FDA has expanded the approval of Zelboraf to include the treatment of certain adult patients with Erdheim-Chester Disease, a rare cancer of the blood...
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FDA approves Vimpat for partial-onset seizures in paediatric epilepsy
FDA approves Vimpat for partial-onset seizures in paediatric epilepsy patients as an oral solution or a convenient tablet...
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FDA approves Vyzulta for open-angle glaucoma and ocular hypertension
The FDA has approved a New Drug Application for Vyzulta for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension....
