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RSS FeedPosted by Michael Wonder on 28 Sep 2020
Blueprint Medicines announces European Commission approval of Ayvakyt (avapritinib) for the treatment of adults with unresectable or metastatic PDGFRA D842V mutant gastro-intestinal stromal tumours
25 September 2020 - First highly effective treatment option approved in Europe for PDGFRA D842V mutant GIST. ...
Posted by Michael Wonder on 28 Sep 2020
FDA approves Bausch & Lomb Alaway preservative free (ketotifen fumarate 0.035% ophthalmic solution)
25 September 2020 - First OTC preservative free eye drop approved for the treatment of itchy eyes associated with allergies. ...
Posted by Michael Wonder on 27 Sep 2020
Medicine shortage fears amid MUA pay dispute
28 September 2020 - Critical medicines are blocked from entering Australia as the supply chain becomes collateral damage in a wharfie ...
Posted by Michael Wonder on 27 Sep 2020
Couple move to America to afford life saving treatment
27 September 2020 - Joseph and Julie Moon are abandoning their dream lives in New Zealand, forced to return to ...
Posted by Michael Wonder on 26 Sep 2020
New treatment available free for haemophilia A patients
26 September 2020 - All Australian governments have agreed to fund a new treatment for haemophilia patients, through our national blood ...
Posted by Michael Wonder on 26 Sep 2020
FDA grants rare paediatric disease designation to volasertib for rhabdomyosarcoma
25 September 2020 - Oncoheroes Biosciences is pleased to announce that the United States FDA has granted the designation of rare ...
Posted by Michael Wonder on 26 Sep 2020
FDA approves Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with CF as early as four months of age
25 September 2020 - Approval provides opportunity to treat the underlying cause of cystic fibrosis earlier than ever before. ...
Posted by Michael Wonder on 26 Sep 2020
European Commission grants marketing authorisation for Jyseleca (filgotinib) for the treatment of adults with moderate to severe active rheumatoid arthritis
25 September 2020 - Jyseleca demonstrated durable efficacy combined with a consistent safety profile in rheumatoid arthritis through 52 weeks in ...
Posted by Michael Wonder on 26 Sep 2020
Aquestive Therapeutics receives complete response letter from FDA for Libervant (diazepam) buccal film for management of seizure clusters
25 September 2020 - No additional clinical studies anticipated by Aquestive. ...
Posted by Michael Wonder on 26 Sep 2020
RemeGen announces US FDA has granted breakthrough therapy designation for disitamab vedotin (RC48) in urothelial cancer
25 September 2020 - RemeGen today announced that the U.S. FDA has granted Breakthrough Therapy designation for disitamab vedotin (RC48), a ...
Posted by Michael Wonder on 25 Sep 2020
FDA approves first drug to treat group of rare blood disorders in nearly 14 years
25 September 2020 - Today, the U.S. FDA approved Nucala (mepolizumab) for adults and children aged 12 years and older with ...
Posted by Michael Wonder on 25 Sep 2020
CRISPR Therapeutics and Vertex Pharmaceuticals announce Priority Medicines (PRIME) designation granted by the EMA to CTX001 for the treatment of sickle cell disease
24 September 2020 - CRISPR Therapeutics and Vertex Pharmaceuticals today announced the EMA has granted Priority Medicines (PRIME) designation to ...
Posted by Michael Wonder on 25 Sep 2020
FDA takes actions to help lower U.S. prescription drug prices
24 September 2020 - Final rule, guidance fulfil plan for safe importation of certain drugs originally intended for foreign markets. ...
Posted by Michael Wonder on 25 Sep 2020
Mereo BioPharma receives FDA rare paediatric disease designation for setrusumab for the treatment of osteogenesis imperfecta
24 September 2020 - Mereo BioPharma today announces that the U.S. FDA has granted rare paediatric disease designation to setrusumab for ...
Posted by Michael Wonder on 24 Sep 2020
Bausch Health announces Vyzulta (latanoprostene bunod 0.024% ophthalmic solution) is now approved in seven countries
24 September 2020 - Recent access wins also make Vyzulta available to more Americans and Canadians. ...