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RSS FeedPosted by Michael Wonder on 16 Nov 2020
Eisai receives approval for indication expansion of anti-epileptic agent Fycompa for use in paediatric patients
16 November 2020 - Eisai announced that it has been received approval from the European Commission for the use of its ...
Posted by Michael Wonder on 16 Nov 2020
Aerie Pharmaceuticals receives positive CHMP opinion for Roclanda in the European Union
13 November 2020 - European Commission Decision Anticipated in Approximately Two Months. ...
Posted by Michael Wonder on 15 Nov 2020
Insmed receives Priority Medicines (PRIME) designation from EMA for brensocatib in patients with non-cystic fibrosis bronchiectasis
13 November 2020 - Insmed today announced that the EMA has granted Priority Medicines (PRIME) designation to brensocatib for the ...
Posted by Michael Wonder on 15 Nov 2020
CHMP recommends EU approval of Roche’s Xofluza (baloxavir marboxil) for the treatment of influenza
13 November 2020 - One-dose, oral Xofluza has been recommended for approval for the treatment of uncomplicated influenza in patients aged ...
Posted by Michael Wonder on 13 Nov 2020
Highlights from 9-12 November CHMP meeting
13 November 2020 - The EMA’s CHMP recommended five medicines for approval at its November 2020 meeting. ...
Posted by Michael Wonder on 13 Nov 2020
EU secures 300 million doses of BioNTech, Pfizer’s COVID-19 vaccine
13 November 2020 - The European Commission has secured a supply deal with BioNTech and Pfizer for 300 million doses ...
Posted by Michael Wonder on 13 Nov 2020
Angelini Pharma and Sunovion Pharmaceutical Europe receive EMA approval for Latuda, first atypical antipsychotic for the treatment of adolescent schizophrenia in patients starting from 13 years of age
12 November 2020 - Angelini Pharma and Sunovion Pharmaceutical Europe announced today the EMA approval for Latuda (lurasidone), with the indication ...
Posted by Michael Wonder on 12 Nov 2020
Janssen submits applications in U.S. and EU seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Darzalex (daratumumab) subcutaneous formulation in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma
12 November 2020 - Applications supported by positive results from the Phase 3 APOLLO trial, which demonstrated longer progression-free survival in ...
Posted by Michael Wonder on 12 Nov 2020
EMA publishes agenda for 9-12 November CHMP meeting
12 November 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Nov 2020
Bayer submits marketing authorization applications for finerenone in the U.S. and the EU for patients with chronic kidney disease and type 2 diabetes
9 November 2020 - Regulatory submissions based on positive data from Phase 3 FIDELIO-DKD trial recently published in the New England ...
Posted by Michael Wonder on 10 Nov 2020
Mirum Pharmaceuticals broadens Expanded Access Program for maralixibat in Alagille syndrome to Europe and Australia
5 November 2020 - Maralixibat Expanded Access Program now available for patients with pruritus associated with Alagille syndrome in Australia and ...
Posted by Michael Wonder on 10 Nov 2020
Orphazyme submits European Marketing Authorisation application for arimoclomol for treatment of Niemann-Pick disease Type C
9 November 2020 - Follows U.S. FDA acceptance of new drug application with priority review in September 2020. ...
Posted by Michael Wonder on 09 Nov 2020
Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia
9 November 2020 - Calquence demonstrated superior progression-free survival and favourable tolerability in both previously untreated and relapsed or refractory ...
Posted by Michael Wonder on 07 Nov 2020
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for first-line treatment of metastatic non-small cell lung cancer
6 November 2020 - Approval based on Phase 3 CheckMate-9LA trial results showing superior overall survival in patients with metastatic non-small ...
Posted by Michael Wonder on 06 Nov 2020
International regulators and WHO join forces to address COVID-19 challenges
6 November 2020 - The International Coalition of Medicines Regulatory Authorities and the World Health Organization have committed to working together ...