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RSS FeedPosted by Michael Wonder on 08 Apr 2020
FDA approves first generic of a commonly used albuterol/salbutamol inhaler to treat and prevent bronchospasm
8 April 2020 - The U.S. FDA today approved the first generic of Proventil HFA (albuterol sulphate/salbutamol sulphate) metered dose inhaler, ...
Posted by Michael Wonder on 08 Apr 2020
Acceleron receives FDA breakthrough therapy designation for sotatercept in pulmonary arterial hypertension
8 April 2020 - Sotatercept granted first FDA breakthrough therapy designation in pulmonary arterial hypertension since the Agency established the designation ...
Posted by Michael Wonder on 08 Apr 2020
Bristol Myers Squibb announces acceptance of U.S. and EU regulatory filings for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy in first-line lung cancer
8 April 2020 - Submissions based on results from Phase 3 CheckMate-9LA trial. ...
Posted by Michael Wonder on 08 Apr 2020
Esperion Announces European Commission approval of the Nustendi (bempedoic acid and ezetimibe) tablet for the treatment of hypercholesterolaemia and mixed dyslipidaemia
6 April 2020 - First non-statin, LDL-C lowering combination medicine ever approved in Europe. ...
Posted by Michael Wonder on 08 Apr 2020
Advanced Accelerator Applications announces Health Canada approval of Netspot diagnostic imaging agent kit to detect neuroendocrine tumours
7 April 2020 - Netspot is the first and only kit for the preparation of gallium (68 Ga) oxodotreotide injection for ...
Posted by Michael Wonder on 08 Apr 2020
Submissions on whether the TGA should publish that a prescription medicine is under evaluation
8 April 2020 - Between 15 February and 29 March 2019, the TGA sought comments from interested parties on the ...
Posted by Michael Wonder on 08 Apr 2020
Genentech provides regulatory update on risdiplam for the treatment of spinal muscular atrophy
7 April 2020 - U.S. FDA extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2. ...
Posted by Michael Wonder on 08 Apr 2020
Alnylam completes rolling submission of new drug application to the U.S. FDA and submits marketing authorisation application to the EMA for lumasiran for the treatment of primary hyperoxaluria type 1
7 April 2020 - Lumasiran is the first potential therapeutic to demonstrate substantial reduction in urinary oxalate excretion. ...
Posted by Michael Wonder on 08 Apr 2020
Agenus receives fast track designation for balstilimab in advanced cervical cancer
7 April 2020 - Agenus today announced that the U.S. FDA has granted Agenus fast track designation for investigation of balstilimab ...
Posted by Michael Wonder on 08 Apr 2020
FDA grants fast track designation to sacituzumab govitecan for urothelial cancer
7 April 2020 - Immunomedics today announced that the U.S. FDA has granted fast track designation for sacituzumab govitecan for the ...
Posted by Michael Wonder on 07 Apr 2020
Blaze Bioscience announces FDA has granted fast track designation to BLZ-100 (tozuleristide) for paediatric central nervous system tumours
7 April 2020 - Phase 2/3 pivotal trial ongoing in patients up to 30 years of age undergoing surgery for paediatric ...
Posted by Michael Wonder on 07 Apr 2020
Merck receives priority review from FDA for second application for Keytruda (pembrolizumab) based on biomarker, regardless of tumour type
7 April 2020 - Supplemental biologics license application accepted for Keytruda monotherapy in patients whose tumours are tumour mutational burden-high who ...
Posted by Michael Wonder on 07 Apr 2020
Global regulators discuss observational studies of real world data for COVID-19 medicines
7 April 2020 - In a dedicated COVID-19 workshop, organised by the EMA under the umbrella of the International Coalition of ...
Posted by Michael Wonder on 07 Apr 2020
India again allows export of anti-malarial drug touted for coronavirus
7 April 2020 - President Trump had urged the country, one of hydroxychloroquine’s biggest producers, to release supplies of the medicine. ...
Posted by Michael Wonder on 07 Apr 2020
Scientists rush to find coronavirus cure—but it still isn’t fast enough
6 April 2020 - For drug companies, there is suddenly only one priority: the coronavirus. ...