News
Viglya wishes to establish transparent and open communication with its stakeholders. This section offers new and updated information regarding the company and the life science sector.
EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020
Ten new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its October 2020 meeting. The Committee recommended granting a conditional marketing authorisation for Tecartus* (autologous anti-CD19-transduced CD3+ cells) for the treatment [...]
EMA: First CAR-T cell medicine for mantle cell lymphoma
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients with a rare cancer of white blood cells called mantle cell lymphoma (MCL) [...]
(Cas) AEMPS: Boletín trimestral de la AEMPS sobre productos sanitarios y cosméticos, julio – septiembre 2020
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Recoge información [...]
FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications
The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs). These changes include new labeling to explain that if women take the medications [...]
EMA cancer symposium: New approaches in patient-focused cancer medicine development
On Thursday, 29 October, EMA is hosting a symposium to discuss new approaches to facilitating and using input from cancer patients to inform medicine development and regulatory decision-making. The agenda of the symposium , which will be [...]
UK medicines regulator joins up with Australia, Canada, Singapore and Switzerland regulators
The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. To accommodate the MHRA joining the group will now be known as the Access Consortium. The aim [...]