Blog
RSS FeedPosted by Michael Wonder on 04 May 2021
Clearside Biomedical announces resubmission of new drug application for Xipere for treatment of macular oedema associated with uveitis
3 May 2021 - Clearside Biomedical announced today the resubmission of its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 04 May 2021
Astellas' Xtandi (enzalutamide) approved by European Commission for men with metastatic hormone sensitive prostate cancer
4 May 2021 - Enzalutamide is now the only oral therapy approved by the European Commission to treat three distinct types ...
Posted by Michael Wonder on 03 May 2021
Doubt over local mRNA plans as major companies pull out of Australia
3 May 2021 - Vaccine development experts say it will take at least $250 million plus the support of a ...
Posted by Michael Wonder on 03 May 2021
Amphastar Pharmaceuticals receives FDA approval for morphine sulphate injection
3 May 2021 - Amphastar Pharmaceuticals announced that the U.S. FDA approved the Company’s abbreviated new drug application for morphine sulphate ...
Posted by Michael Wonder on 03 May 2021
ImmunoMet Therapeutics granted fast track designation by U.S. FDA for IM156 in idiopathic pulmonary fibrosis
3 May 2021 - ImmunoMet Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead compound ...
Posted by Michael Wonder on 03 May 2021
Intra-Cellular Therapies announces FDA acceptance of Caplyta (lumateperone) sNDAs for the treatment of bipolar depression
3 May 2021 - Intra-Cellular Therapies today announced that the U.S. FDA has accepted for review its supplemental new drug applications ...
Posted by Michael Wonder on 03 May 2021
How the FDA’s ‘master plan’ will affect NIH funding for digital medicine projects
3 May 2021 - The term B.C. took on a new meaning — Before COVID — last year when almost ...
Posted by Michael Wonder on 03 May 2021
TGA approves key label updates to Buvidal for treatment of opioid dependence
3 May 2021 - Camurus today announced that the Australian regulatory agency, the TGA, has approved key label updates to ...
Posted by Michael Wonder on 03 May 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15
3 May 2021 - EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to ...
Posted by Michael Wonder on 03 May 2021
Hutchmed completes rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
3 May 2021 - First NDA submission by Hutchmed in the U.S.; product launch preparations underway. ...
Posted by Michael Wonder on 03 May 2021
Statement from Health Canada on Janssen COVID-19 vaccines and Emergent BioSolutions
30 April 2021 - Health Canada continues to ensure the quality and safety of vaccines coming into Canada by working ...
Posted by Michael Wonder on 03 May 2021
ALS groups to the FDA and drug sponsors: ‘We won’t be played again’
30 April 2021 - Working to improve the fight for therapies for amyotrophic lateral sclerosis (ALS, also known as Lou ...
Posted by Michael Wonder on 03 May 2021
Chiesi Global Rare Diseases announces FDA approval of Ferriprox (deferiprone) for treatment of transfusional iron overload due to sickle cell disease
1 May 2021 - Approval is based on demonstrated reduction in liver iron concentration. ...
Posted by Michael Wonder on 03 May 2021
FDA scraps another last-minute Trump-era policy
30 April 2021 - The US FDA on Friday revoked a policy issued in the final days of the Trump ...
Posted by Michael Wonder on 03 May 2021
BioCryst receives European Commission approval of Orladeyo (berotralstat), first oral, once daily therapy to prevent attacks in hereditary angioedema patients
30 April 2021 - BioCryst Pharmaceuticals today announced that the European Commission has approved oral, once daily Orladeyo (berotralstat) for ...