Blog
RSS FeedPosted by Michael Wonder on 04 Apr 2019
Vizimpro (dacomitinib) receives marketing authorisation in European Union for the first-line treatment of adult patients with EGFR mutated non-small cell lung cancer
3 April 2019 - Pfizer today announced that the European Commission has approved Vizimpro (dacomitinib), a tyrosine kinase inhibitor, as monotherapy ...
Posted by Michael Wonder on 23 Mar 2019
Genmab announces European regulatory submission for daratumumab in combination with lenalidomide and dexamethasone in frontline multiple myeloma
22 March 2019 - Type II variation application submitted to the EMA for daratumumab in combination with lenalidomide and dexamethasone as ...
Posted by Michael Wonder on 14 Mar 2019
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with chemotherapy for first-line treatment of adults with metastatic squamous non-small cell lung cancer
14 March 2019 - European approval based on KEYNOTE-407 study results demonstrating significant improvement in overall survival with Keytruda in combination ...
Posted by Michael Wonder on 10 Mar 2019
Bayer submits European marketing authorisation application for darolutamide
8 March 2019 - Third submission for darolutamide in two weeks underscores Bayer's commitment to fill an unmet need for men ...
Posted by Michael Wonder on 08 Mar 2019
European Medicines Agency validates application for Bavencio (avelumab) plus Inlyta (axitinib) for the treatment of advanced renal cell carcinoma
8 March 2019 - Merck and Pfizer today announced that the EMA has validated for review the Type II variation ...
Posted by Michael Wonder on 04 Mar 2019
European Medicines Agency adopts positive opinion for Merck’s Keytruda (pembrolizumab) for six-week dosing schedule across all current monotherapy indications
4 March 2019 - Merck today announced that the CHMP of the EMA has recommended the approval of a new ...
Posted by Michael Wonder on 02 Mar 2019
Lynparza receives positive EU CHMP opinion for use in germline BRCA-mutated HER2-negative advanced breast cancer
1 March 2019 - AstraZeneca and MSD today announced that the CHMP of the EMA has adopted a positive opinion, ...
Posted by Michael Wonder on 02 Mar 2019
Pfizer receives positive CHMP opinion for Lorviqua (lorlatinib) for certain adult patients with previously-treated ALK-positive advanced non-small cell lung cancer
1 March 2019 - Pfizer today announced that the CHMP of the EMA has adopted a positive opinion for Lorviqua (lorlatinib, ...
Posted by Michael Wonder on 01 Mar 2019
Astellas announces acceptance of Xospata (gilteritinib) for regulatory review by the European Medicines Agency
28 February 2019 - Astellas Pharma announced today that the submission for a marketing authorisation application for the oral once-daily ...
Posted by Michael Wonder on 27 Feb 2019
Celgene Corporation announces key regulatory update for Revlimid in lymphoma
26 February 2019 - U.S. FDA grants priority review for Revlimid (lenalidomide) in combination with rituximab for previously treated follicular and ...
Posted by Michael Wonder on 12 Feb 2019
Seattle Genetics achieves $30 million milestone payment for European Commission approval of Adcetris (brentuximab vedotin) in frontline Hodgkin lymphom
11 February 2019 - Seattle Genetics today announced that its collaborator Takeda has received approval from the European Commission to ...
Posted by Michael Wonder on 11 Feb 2019
European Commission approves Bristol-Myers Squibb’s Sprycel (dasatinib) in combination with chemotherapy for treatment of paediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia
11 February 2019 - Bristol-Myers Squibb today announced that the European Commission has approved Sprycel (dasatinib) in combination with chemotherapy ...
Posted by Michael Wonder on 03 Feb 2019
CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer
1 February 2019 - Recommendation based on the Phase III IMpower150 study which showed that Tecentriq (atezolizumab) in combination with Avastin ...
Posted by Michael Wonder on 03 Feb 2019
Pfizer receives positive CHMP opinion for Vizimpro (dacomitinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations
2 February 2019 - Pfizer today announced that the CHMP of the EMA has adopted a positive opinion recommending Vizimpro ...
Posted by Michael Wonder on 02 Feb 2019
CTI BioPharma receives results of the CHMP oral explanation for pacritinib in the treatment of myelofibrosis and provides development update
1 February 2019 - CTI BioPharma today announced that the Company will withdraw its European marketing authorisation application for pacritinib ...