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RSS FeedPosted by Michael Wonder on 05 May 2021
Roche’s Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer
5 May 2021 - This approval marks Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung ...
Posted by Michael Wonder on 04 May 2021
Pfizer will file for full FDA approval by end of May
4 May 2021 - Pfizer and BioNTech, the manufacturers of one of the three authorised COVID-19 vaccines in the U.S., plan ...
Posted by Michael Wonder on 04 May 2021
TGA approves new treatment for aggressive form of prostate cancer
5 May 2021 - The TGA has registered a new medication to treat a particularly aggressive and advanced type of ...
Posted by Michael Wonder on 04 May 2021
ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV
4 May 2021 - If approved, cabotegravir would be the first, long-acting therapy for HIV PrEP. ...
Posted by Michael Wonder on 04 May 2021
Australia's TGA grants approval to first objective concussion diagnostic
4 May 2021 - Oculogica's EyeBOX is the only objective diagnostic cleared by the US FDA and Australia TGA as an ...
Posted by Michael Wonder on 04 May 2021
Micro Medical Solutions receives FDA breakthrough device designation for MicroStent vascular stent
4 May 2021 - Breakthrough designation helps advance treatment options, targeting a significant unmet need in the treatment of critical limb-threatening ischaemia. ...
Posted by Michael Wonder on 04 May 2021
SIGA announces new drug application filing with FDA for intravenous formulation of TPOXX
4 May 2021 - Important for patients who cannot swallow oral capsules. ...
Posted by Michael Wonder on 04 May 2021
EMA starts rolling review of COVID-19 vaccine (Vero Cell) inactivated
4 May 2021 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine (Vero Cell) inactivated, developed by Sinovac ...
Posted 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 ...