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RSS FeedPosted by Michael Wonder on 20 Dec 2021
CHMP issues positive opinion for Pfizer’s 20 valent pneumococcal conjugate vaccine for the prevention of vaccine type pneumococcal pneumonia in adults
17 December 2021 - Pfizer announced today that the CHMP of the EMA has issued a positive opinion to recommend the ...
Posted by Michael Wonder on 19 Dec 2021
Pfizer receives positive CHMP opinion for Lorviqua (lorlatinib) as first-line treatment for ALK positive advanced lung cancer
17 December 2021 - Recommendation based on results from the Phase 3 CROWN trial, which showed Lorviqua reduced the risk of ...
Posted by Michael Wonder on 18 Dec 2021
Astellas and Seagen receive positive CHMP opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
17 December 2021 - If approved, PADCEV would be the first medicine for patients in the EU who have received prior ...
Posted by Michael Wonder on 13 Dec 2021
EMA publishes agenda for 13-16 CHMP meeting
13 December 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 Nov 2021
EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19
19 November 2021 - EMA’s CHMP has issued advice on the use of Lagevrio (molnupiravir, MK 4482) for the treatment of ...
Posted by Michael Wonder on 15 Nov 2021
Horizon Therapeutics receives CHMP positive opinion for Uplinza (inebilizumab) as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder
12 November 2021 - CHMP recommendation based on positive results from N-MOmentum, the largest clinical trial ever conducted in NMOSD to ...
Posted by Michael Wonder on 15 Nov 2021
Ozempic 2 mg recommended for approval for the treatment of type 2 diabetes by the European Medicines Agency
12 November 2021 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion recommending a label ...
Posted by Michael Wonder on 15 Nov 2021
Wegovy recommended for approval for the treatment of obesity by the European regulatory authorities
11 November 2021 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 13 Nov 2021
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in children with cystic fibrosis ages 6 through 11
12 November 2021 - If approved, more than 1,500 children would be eligible for a medicine that can treat the ...
Posted by Michael Wonder on 13 Nov 2021
Highlights from CHMP 8-11 November 2021 meeting
12 November 2021 - EMA’s CHMP recommended eleven medicines for approval at its November 2021 meeting. ...
Posted by Michael Wonder on 12 Nov 2021
First in class medicine recommended for treatment of rare blood vessel inflammation
12 November 2021 - EMA has recommended granting a marketing authorisation in the European Union for Tavneos (avacopan), a first in ...
Posted by Michael Wonder on 08 Nov 2021
EMA publishes agenda for 8-11 November CHMP meeting
8 November 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 08 Nov 2021
SMC - November 2021 decisions
8 November 2021 - The Scottish Medicines Consortium which advises on newly licensed medicines for use by NHSScotland has published ...
Posted by Michael Wonder on 17 Oct 2021
Pfizer’s abrocitinib receives positive CHMP opinion for the treatment of adults with moderate to severe atopic dermatitis
15 October 2021 - CHMP also recommends Xeljanz (tofacitinib) approval for the treatment of adults with active ankylosing spondylitis ...
Posted by Michael Wonder on 17 Oct 2021
Merck and Eisai receive positive EU CHMP opinions for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) in two different types of cancer
15 October 2021 - Merck and Eisai today announced that the CHMP of the EMA has adopted positive opinions recommending ...