FDA approves the inclusion of new evidence for Cosentyx in PsA
25 June 2018 | By European Pharmaceutical Review
The FDA has approved the inclusion of new evidence that Cosentyx significantly slows the progression of joint structural damage..
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Regs & Legs
Issue 3, 2018
22 June 2018 | By European Pharmaceutical Review
In this issue: Microfluidics technology in pharmaceutical research, drug manufacturing and development, and is supercritical fluid chromatography applicable to achiral separations?
FDA approves first generic versions of Suboxone for opioid dependence
19 June 2018 | By European Pharmaceutical Review
The FDA has approved the first generic versions of Suboxone sublingual film for the treatment of opioid dependence...
SMC approves Xermelo for carcinoid syndrome diarrhoea
13 June 2018 | By European Pharmaceutical Review
Scotland is the first country in the UK to enable patients, battling this serious and debilitating condition, access to a new treatment option...
SCIEX OS 1.4 launches with next-generation algorithms and complete data processing compatibility across SCIEX mass spectrometry platforms
11 June 2018 | By Sciex
New software offers improved workflow efficiency with enhanced data management and the tools to support 21 CFR Part 11 compliance across the SCIEX mass spectrometry portfolio...
EMA recommends marketing authorisation to Tegsedi for hereditary transthyretin amyloidosis
7 June 2018 | By European Pharmaceutical Review
The EMA has recommended granting a marketing authorisation for Tegsedi, a medicine for the treatment of stage 1 or stage 2 polyneuropathy...
European Pharmaceutical Review: Our 5 Steps to GDPR Compliance
7 June 2018 | By European Pharmaceutical Review
The General Data Protection Regulation (GDPR) is a new set of EU rules governing how a company manages, protects and administers personal data. Whether you are a subscriber, author, advertiser or supplier to our journal, we may hold information about you and we need to keep it private and secure.
Navigating data management challenges in the pharmaceutical life cycle
6 June 2018 | By Abbott Informatics
In this webinar, we’ll introduce you to laboratory information management systems (LIMS) and demonstrate how this software can help you achieve regulatory compliance, quality data management throughout your product’s lifecycle...
FDA approves first biosimilar to Neulasta
5 June 2018 | By European Pharmaceutical Review
The U.S. Food and Drug Administration has approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment.
FDA accepts Larotrectinib New Drug Application and Grants Priority Review
31 May 2018 | By European Pharmaceutical Review
The FDA has accepted the NDA and granted Priority Review for larotrectinib for advanced or metastatic solid tumours harbouring a NTRK gene fusion...
FDA approves Palynziq for PKU, a rare and serious genetic disease
28 May 2018 | By European Pharmaceutical Review
Novel enzyme therapy for adults with PKU who have uncontrolled blood phenylalanine concentrations with current treatment...
FDA approves Doptelet for thrombocytopenia in chronic liver disease
25 May 2018 | By European Pharmaceutical Review
The FDA has approved Doptelet tablets to treat low blood platelet count in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure...
FDA approves Prolia for glucocorticoid-induced osteoporosis
24 May 2018 | By European Pharmaceutical Review
The FDA has approved the use of Prolia for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture...
FDA approves Aimovig as a preventive treatment for migraines
23 May 2018 | By Dr Zara Kassam (European Pharmaceutical Review)
The FDA has approved Aimovig for the preventive treatment of a migraine in adults. The treatment is given by once-monthly self-injections...
FDA expands approval of Gilenya to treat multiple sclerosis in paediatric patients
16 May 2018 | By European Pharmaceutical Review
The FDA has approved Gilenya to treat relapsing multiple sclerosis in children and adolescents age 10 years and older...
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