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RSS FeedPosted by Michael Wonder on 14 Sep 2022
Minoryx‘s marketing authorisation application for its lead candidate leriglitazone validated by EMA for orphan indication X-linked adrenoleukodystrophy
14 September 2022 - 4, 2022 - Minoryx Therapeutics today announces that it has filed a marketing authorisation application for its ...
Posted by Michael Wonder on 13 Sep 2022
Clovis Oncology submits applications for Rubraca label expansion in the US and European Union as first-line maintenance treatment in women with advanced ovarian cancer
13 September 2022 - Submissions based on data from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented ...
Posted by Michael Wonder on 13 Sep 2022
Novavax Nuvaxovid COVID-19 vaccine granted expanded conditional marketing authorisation in the European Union for use as a booster for adults aged 18 and older
12 September 2022 - Nuvaxovid is now authorised in the EU for use in adults aged 18 and older as ...
Posted by Michael Wonder on 12 Sep 2022
EMA publishes agenda for 12-15 September 2022 CHMP meeting
12 September 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Sep 2022
Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
12 September 2022 - The EMA’s CHMP has recommended authorising an adapted bivalent vaccine targeting the Omicron sub-variants BA.4 and ...
Posted by Michael Wonder on 09 Sep 2022
FDA and EMA accept regulatory submission for Pfizer’s ritlecitinib for individuals 12 years and older with alopecia areata
9 September 2022 - Filings based on clinical data demonstrating significant scalp hair regrowth versus placebo. ...
Posted by Michael Wonder on 07 Sep 2022
Rhythm Pharmaceuticals announces Imcivree (setmelanotide) granted marketing authorisation by European Commission for treatment of obesity and control of hunger in Bardet-Biedl syndrome
6 September 2022 - Setmelanotide now FDA approved and EC authorized for Bardet-Biedl syndrome. ...
Posted by Michael Wonder on 07 Sep 2022
EMA refused rolling review of SK Bioscience's COVID-19 vaccine
7 September 2022 - The EMA refused a rolling review of SK Bioscience's COVID-19 vaccine, SKYCovine, due to “changing pandemic ...
Posted by Michael Wonder on 06 Sep 2022
ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
6 September 2022 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...
Posted by Michael Wonder on 06 Sep 2022
Sanofi sees EU regulatory decision on its COVID booster in weeks
5 September 2022 - The European Union's drugs regulator may be a few weeks from deciding whether to approve the ...
Posted by Michael Wonder on 01 Sep 2022
EMA CHMP adopts positive opinion recommending authorisation for the use of Moderna's Omicron targeting bivalent booster in the European Union
1 September 2022 - Study results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 sub-variants when ...
Posted by Michael Wonder on 01 Sep 2022
First adapted COVID-19 booster vaccines recommended for approval in the EU
1 September 2022 - The EMA’s CHMP has recommended authorising two vaccines adapted to provide broader protection against COVID-19. ...
Posted by Michael Wonder on 30 Aug 2022
Accelerating clinical trials in the EU: publication of 2022-2026 workplan
30 August 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published the 2022-2026 workplan ...
Posted by Michael Wonder on 30 Aug 2022
EMA announces withdrawal of two submissions for cancer medicines
30 August 2022 - The information is somewhat buried on the EMA website. ...
Posted by Michael Wonder on 30 Aug 2022
Novartis Scemblix, with novel mechanism of action, approved by the European Commission for adult patients with chronic myeloid leukaemia
29 August 2022 - Approval based on results from pivotal Phase 3 ASCEMBL trial, in which Scemblix (asciminib) nearly doubled the ...