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February 15, 2024
PARSIPPANY, N.J.--(BUSINESS WIRE)--Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today the positive outcome of the Decentralised Procedure (DCP) for VIGZIP™ (vigabatrin oral solution) in Europe. This significant mile...
June 16, 2023
Paris , 22 April 2021 - Ipsen , a global specialty-driven biopharmaceutical group, publishes its sales performance for the first quarter of 2021: Q1 2021 sales summary ... | June 16, 2023
July 21, 2022
Press release content from PR Newswire. The AP news staff was not involved in its creation.
February 23, 2022
This article reviews the essential regulatory considerations surrounding medicines and medical devices in Malta, including clinical trials and marketing authorisations.
February 23, 2022
This article reviews the essential regulatory considerations surrounding medicines and medical devices in Italy, including clinical trials and marketing authorisations.
December 22, 2021
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
December 10, 2021
After a regulatory update, the Telix share price is falling on Friday morning. Here are the details.
April 22, 2021
Ipsen : Delivers Encouraging Sales Growth in the First Quarter of 2021 Despite the Pandemic, and Confirms Its Full-Year Guidance 04/22/2021 | 01:01am EDT Send by mail : Message : Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, publishes its sales performance for the first quarter of 2021: Q1 2021 sales summary Highlights Total Sales growth of 5.5% at CER, or 0.6% as reported, to €658.5m, despite impact of the pandemic An increase in Spec...
April 22, 2021
Press release content from Business Wire. The AP news staff was not involved in its creation. Ipsen Delivers Encouraging Sales Growth in the First Quarter of 2021 Despite the Pandemic, and Confirms Its Full-Year Guidance April 22, 2021 GMT Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, publishes its sales performance for the first quarter of 2021: Q1 2021 sales summary Highlights Total Sales growth of 5.5% at CER, or 0.6% as reported, to ...
January 1, 2021
Apply for a licence to market a medicine in the UK How to license a medicine for sale in the UK, including applications through national and international routes. From: Contents Print this page This guidance also covers licensing a medicine in Northern Ireland through the centralised, decentralised and mutual recognition European procedures. Which procedure to follow There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotla...