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RSS FeedPosted by Michael Wonder on 17 Nov 2019
Tricida announces FDA acceptance of new drug application for veverimer
14 November 2019 - Tricida announced today that the U.S. FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 17 Nov 2019
CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment
15 November 2019 - Kadcyla cut the risk of disease recurrence or death by half compared to Herceptin in the adjuvant ...
Posted by Michael Wonder on 17 Nov 2019
CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma
15 November 2019 - First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells. ...
Posted by Michael Wonder on 16 Nov 2019
Novartis receives positive CHMP opinion for Mayzent (siponimod) for the treatment of adult patients with active secondary progressive multiple sclerosis
15 November 2019 - If approved, Mayzent (siponimod) will be the first and only oral treatment specifically indicated for patients ...
Posted by Michael Wonder on 15 Nov 2019
Highlights from the CHMP 11-14 November 2019 meeting
15 November 2019 - Seven new medicines recommended for approval. ...
Posted by Michael Wonder on 15 Nov 2019
Dutch authorities hand over final building to EMA in Amsterdam
15 November 2019 - Today, the Dutch authorities have handed over to EMA its newly built tailor-made premises, located in ...
Posted by Michael Wonder on 15 Nov 2019
FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease
15 November 2019 - Today, the U.S. FDA approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – ...
Posted by Michael Wonder on 15 Nov 2019
Valeo Pharma announces filing of a new drug submission for low molecular weight heparin in Canada
14 November 2019 - Valeo Pharma announced today that the new drug submission filed for a low molecular weight heparin ...
Posted by Michael Wonder on 14 Nov 2019
FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance
14 November 2019 - The U.S. FDA today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of ...
Posted by Michael Wonder on 14 Nov 2019
FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumour shrinkage
14 November 2019 - Today, the U.S. FDA granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients ...
Posted by Michael Wonder on 14 Nov 2019
Anavex Life Sciences receives rare paediatric disease designation from FDA for Anavex 2-73 (blarcamesine) for the treatment of Rett syndrome
14 November 2019 - Anavex Life Sciences today announced that it received the rare paediatric disease designation from the U.S. FDA ...
Posted by Michael Wonder on 14 Nov 2019
Researchers call on FDA to rethink guidance allowing use of surrogate outcomes
13 November 2019 - The US FDA needs to reconsider its use of surrogate outcomes in some guidance documents on ...
Posted by Michael Wonder on 14 Nov 2019
US FDA accepts regulatory submission for selumetinib in neurofibromatosis type 1 and grants priority review
14 November 2019 - AstraZeneca and MSD’s selumetinib would become the first medicine indicated for the treatment of paediatric patients with ...
Posted by Michael Wonder on 14 Nov 2019
To drive down insulin prices, WHO will certify generic versions
13 November 2019 - About 80 million people with diabetes around the world need the hormone, and half of them can’t ...
Posted by Michael Wonder on 14 Nov 2019
Watched by Apple
14 November 2019 - After taking over media, social communication, and the consumer economy, the forces of digital innovation are moving ...