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RSS FeedPosted 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
Innova Therapeutics receives rare paediatric disease designation from the FDA for IVT-8086 for the treatment of osteosarcoma
24 September 2020 - Innova Therapeutics Inc., a biopharmaceutical company committed to developing innovative cancer therapies for patients who have inadequate ...
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
AstraZeneca boss says transparency key for vaccine
24 September 2020 - The chief executive of AstraZeneca has said the public must trust that multiple regulators will review ...
Posted by Michael Wonder on 24 Sep 2020
'Pharma resistance’ to battle superbugs
24 September 2020 - A group of pharmaceutical giants, biotech companies, industry peak bodies and the CSIRO have banded together ...
Posted by Michael Wonder on 24 Sep 2020
bluebird bio’s LentiGlobin for sickle cell disease gene therapy (bb1111) granted priority medicines (PRIME) designation by European Medicines Agency
23 September 2020 - EMA’s PRIME program designed to optimise development and expedite evaluation of innovative medicines for patients with high ...
Posted by Michael Wonder on 24 Sep 2020
FDA grants AT-007 paediatric rare disease designation and orphan designation for treatment of PMM2-CDG
24 September 2020 - Applied Therapeutics announced today that the U.S. FDA has granted AT-007 both paediatric rare disease designation and ...
Posted by Michael Wonder on 24 Sep 2020
FDA grants Spirovant Sciences orphan drug and rare paediatric disease designations for SPIRO-2101 for treatment of cystic fibrosis
24 September 2020 - Spirovant Sciences today announced that the U.S. FDA has granted orphan drug and rare paediatric disease ...