Blog
RSS FeedPosted by Michael Wonder on 22 Jun 2021
Jardiance (empagliflozin) approved in Europe for the treatment of heart failure with reduced ejection fraction
21 June 2021 - This new indication is based on the EMPEROR Reduced trial, which showed a significant 25% reduction in ...
Posted by Michael Wonder on 22 Jun 2021
Bristol Myers Squibb receives European Commission approval for Onureg (azacitidine tablets) as frontline oral maintenance therapy for adults with acute myeloid leukaemia
18 June 2021 - Onureg is the first and only once daily, frontline oral maintenance therapy in the European Union for ...
Posted by Michael Wonder on 18 Jun 2021
European Commission approves Aubagio (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis
18 June 2021 - The European Commission has approved Aubagio (teriflunomide) for the treatment of paediatric patients 10 to 17 years ...
Posted by Michael Wonder on 10 Jun 2021
Copiktra (duvelisib) receives European Union marketing authorisation for the treatment of relapsed or refractory CLL and refractory FL
9 June 2021 - Secura Bio today announced that on 19 May 2021, the European Medicines Agency granted marketing authorisation for ...
Posted by Michael Wonder on 01 Jun 2021
Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine
1 June 2021 - EMA has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in ...
Posted by Michael Wonder on 30 May 2021
Diurnal receives European Commission approval for Efmody
28 May 2021 - Commercial launch anticipated in Q3 2021. ...
Posted by Michael Wonder on 28 May 2021
Tagrisso approved in the EU for the adjuvant treatment of patients with early stage EGFR mutated lung cancer
28 May 2021 - Approval based on unprecedented results from the ADAURA Phase 3 trial where Tagrisso reduced the risk ...
Posted by Michael Wonder on 25 May 2021
AbbVie receives European Commission approval of Venclyxto (venetoclax) in combination with a hypomethylating agent for patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
25 May 2021 - Venclyxto (venetoclax) in combination with a hypomethylating agent is a new regimen approved by the European ...
Posted by Michael Wonder on 25 May 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as first-line treatment for certain patients with oesophageal cancer or HER2 negative gastro-oesophageal junction adenocarcinoma
24 May 2021 - Recommendation based on significant survival benefit demonstrated with Keytruda plus chemotherapy versus chemotherapy in Phase 3 KEYNOTE-590 ...
Posted by Michael Wonder on 25 May 2021
European Commission approves Ponvory (ponesimod) for the treatment of adults with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features
25 May 2021 - Idorsia was informed by the Janssen that the European Commission has approved Ponvory (ponesimod) for the treatment ...
Posted by Michael Wonder on 24 May 2021
Positive CHMP opinion for Ryeqo (relugolix combination tablet)
21 May 2021 - Gedeon Richter announces that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 24 May 2021
Bristol Myers Squibb receives positive CHMP opinion recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for treatment of mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer after prior chemotherapy
21 May 2021 - Application based on positive results from the Phase 2 CheckMate-142 trial demonstrating a durable clinical benefit in ...
Posted by Michael Wonder on 23 May 2021
Positive CHMP opinion for Bayer’s new symptomatic chronic heart failure treatment vericiguat
21 May 2021 - Vericiguat is being considered for adult patients with reduced ejection fraction who are stabilised after a recent ...
Posted by Michael Wonder on 23 May 2021
First gene therapy to treat children with rare inherited neurological disease
21 May 2021 - The EMA has recommended granting a marketing authorisation in the European Union for the gene therapy ...
Posted by Michael Wonder on 23 May 2021
New treatment for obesity caused by rare genetic disorders
21 May 2021 - EMA has recommended granting a marketing authorisation in the European Union for Imcivree (setmelanotide) to support weight ...