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RSS FeedPosted by Michael Wonder on 18 Jun 2021
Orphazyme provides regulatory update from FDA on arimoclomol for Niemann-Pick disease type C
18 June 2021 - Orphazyme today announced it has received a complete response letter from the U.S. FDA following its ...
Posted by Michael Wonder on 18 Jun 2021
Outcomes of the May 2021 PBAC intracycle meeting
18 June 2021 - The outcomes from the May 2021 PBAC meeting are now available. ...
Posted by Michael Wonder on 17 Jun 2021
Dupixent (dupilumab) pre-filled pen now available in Canada, providing convenient self-administration option for people with type 2 inflammatory diseases
17 June 2021 - The pre-filled pen offers an additional administration option for all Dupixent indications in patients aged 12 years ...
Posted by Michael Wonder on 17 Jun 2021
FDA approves a nasal anti-histamine for non-prescription use
17 June 2021 - The U.S. FDA today approved a nasal antihistamine for nonprescription use through a process called a partial ...
Posted by Michael Wonder on 17 Jun 2021
Ontozry scores MHRA authorisation for focal-onset seizures
17 June 2021 - The MHRA has granted Arvelle Therapeutics’ Ontozry a marketing authorisation for the adjunctive treatment of focal-onset ...
Posted by Michael Wonder on 16 Jun 2021
FDA approves avapritinib for advanced systemic mastocytosis
16 June 2021 - On June 16, 2021, the FDA approved avapritinib (Ayvakit, Blueprint Medicines) for adult patients with advanced ...
Posted by Michael Wonder on 15 Jun 2021
FDA approves StrataGraft for the treatment of adults with thermal burns
15 June 2021 - Today, the U.S. FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact ...
Posted by Michael Wonder on 15 Jun 2021
Eton Pharmaceuticals announces FDA approval of Rezipres (ephedrine hydrochloride injection)
15 June 2021 - Eton Pharmaceuticals today announced that the U.S. FDA has approved Rezipres (ephedrine hydrochloride injection) for the treatment ...
Posted by Michael Wonder on 15 Jun 2021
Medtronic announces FDA approval of its next generation recharge-free spinal cord stimulation platform
10 June 2021 - Vanta implantable neurostimulator offers up to 11 year battery life and personalised pain relief. ...
Posted by Michael Wonder on 15 Jun 2021
Avenue Therapeutics receives complete response letter from the FDA for intravenous tramadol
14 June 2021 - Avenue Therapeutics today announced that it has received a second complete response letter from the U.S. ...
Posted by Michael Wonder on 11 Jun 2021
Sanofi provides update on Aubagio (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S
11 June 2021 - The U.S. FDA has issued a complete response letter regarding the supplemental new drug application for ...
Posted by Michael Wonder on 11 Jun 2021
Delytact oncolytic virus G47∆ approved in Japan for treatment of patients with malignant glioma
10 June 2021 - First oncolytic virus ever approved for treatment of malignant glioma or any primary brain cancer. ...
Posted by Michael Wonder on 10 Jun 2021
Health Canada grants interim order authorisation for casirivimab and imdevimab for the treatment of mild to moderate COVID-19
10 June 2021 - Interim data shows treatment with casirivimab and imdevimab resulted in a statistically significant reduction in viral ...
Posted by Michael Wonder on 10 Jun 2021
Astellas’ Xtandi bags NICE approval in prostate cancer
10 June 2021 - Astellas’ oral treatment Xtandi has received approval from NICE for the treatment of metastatic hormone-sensitive prostate ...
Posted by Michael Wonder on 10 Jun 2021
NICE recommends several treatment options to help thousands with moderate rheumatoid arthritis
10 June 2021 - Around 25,000 people with moderate rheumatoid arthritis that has not responded to conventional therapies are set to ...