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RSS FeedPosted by Michael Wonder on 21 Dec 2022
European Commission approves Eladynos (abaloparatide) for the treatment of osteoporosis in post-menopausal women at increased risk of fracture
19 December 2022 - Radius Health announced that the European Commission has granted marketing authorisation for abaloparatide under the trade name ...
Posted by Michael Wonder on 21 Dec 2022
Lynparza in combination with abiraterone approved in the EU as first-line treatment for patients with metastatic castration-resistant prostate cancer
21 December 2022 - First approved PARP inhibitor to demonstrate clinically meaningful benefits in combination with a new hormonal agent. ...
Posted by Michael Wonder on 21 Dec 2022
Imfinzi plus chemotherapy approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer
21 December 2022 - Approval based on TOPAZ-1 updated survival results showing Imfinzi combination reduced risk of death by 24% ...
Posted by Michael Wonder on 20 Dec 2022
Albireo submits Bylvay Alagille syndrome regulatory filings to FDA and EMA
19 December 2022 - Gold standard Phase 3 ASSERT study supports supplementary filings in the US and EU. ...
Posted by Michael Wonder on 19 Dec 2022
Forxiga recommended for approval in the EU by CHMP for symptomatic chronic heart failure
19 December 2022 - f approved, Forxiga will be the first heart failure therapy indicated across the full ejection fraction ...
Posted by Michael Wonder on 19 Dec 2022
Enhertu recommended for approval in the EU by CHMP for patients with HER2 low metastatic breast cancer
19 December 2022 - AstraZeneca and Daiichi Sankyo’s Enhertu is the first HER2 directed therapy to demonstrate a significant survival ...
Posted by Michael Wonder on 19 Dec 2022
Imfinzi plus Imjudo recommended for approval in the EU by CHMP for the treatment of advanced liver and lung cancers
19 December 2022 - Positive opinions based on significant survival benefit in HIMALAYA and POSEIDON Phase 3 trials. ...
Posted by Michael Wonder on 19 Dec 2022
Fintepla (fenfluramine) oral solution recommended for approval in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
19 December 2022 - Recommendation based on Phase 3 trial data demonstrating safety and efficacy in the most difficult to treat ...
Posted by Michael Wonder on 18 Dec 2022
Apellis submits marketing authorisation application to the EMA for pegcetacoplan for geographic atrophy
16 December 2022 - Apellis Pharmaceuticals today announced that the company has submitted a marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 18 Dec 2022
Amicus Therapeutics receives positive CHMP opinion for Pombiliti (cipaglucosidase alfa) for late-onset Pompe disease
16 December 2022 - CHMP adopts positive opinion based upon complete review of all pre-clinical, clinical studies and CMC data. ...
Posted by Michael Wonder on 18 Dec 2022
Finerenone receives positive CHMP opinion for EU label extension for broad range of patients with chronic kidney disease and type 2 diabetes
16 December 2022 - CHMP opinion is based on the results from the Phase 3 FIGARO-DKD cardiovascular outcomes trial in patients ...
Posted by Michael Wonder on 18 Dec 2022
CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
16 December 2022 - The positive CHMP opinion is based on the results of the HAVEN 6 trial, which demonstrated effective ...
Posted by Michael Wonder on 16 Dec 2022
Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic oesophagitis
16 December 2022 - If approved, Dupixent would be the first and only targeted medicine specifically indicated for people aged 12 ...
Posted by Michael Wonder on 15 Dec 2022
Dupixent (dupilumab) approved by European Commission as the first and only targeted medicine indicated for prurigo nodularis
15 December 2022 - Approval based on direct to Phase 3 program showing more than three times as many Dupixent patients ...
Posted by Michael Wonder on 13 Dec 2022
EMA publishes agenda for the 12-15 December CHMP meeting
12 December 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...