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RSS FeedPosted by Michael Wonder on 28 Nov 2020
Polaryx Therapeutics receives both rare paediatric disease and orphan drug designations for the treatment of GM2 gangliosidosis with PLX-300
25 November 2020 - Polaryx Therapeutics announced today that it has received from the U.S. FDA both rare paediatric disease and ...
Posted by Michael Wonder on 28 Nov 2020
FDA approves first treatment for weight management for people with certain rare genetic conditions
27 November 2020 - The U.S. FDA has approved Imcivree (setmelanotide) for chronic weight management (weight loss and weight maintenance for ...
Posted by Michael Wonder on 28 Nov 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce extension of PDUFA date for pegunigalsidase alfa for the proposed treatment of Fabry disease
27 November 2020 - Protalix BioTherapeutics today announced that the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) ...
Posted by Michael Wonder on 27 Nov 2020
Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up
27 November 2020 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all stakeholders, ...
Posted by Michael Wonder on 26 Nov 2020
TGA announces approval of new medicine from ASX listed company
26 November 2020 - Afamelanotide acetate (Scenesse) was approved on 22 October 2020. ...
Posted by Michael Wonder on 26 Nov 2020
After admitting mistake, AstraZeneca faces difficult questions about its vaccine
25 November 2020 - Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures ...
Posted by Michael Wonder on 26 Nov 2020
European Medicines Agency validates application for tepotinib for the treatment of advanced NSCLC with METex14 skipping alterations
26 November 2020 - Merck today announced that the EMA has validated for review, the application for tepotinib for the ...
Posted by Michael Wonder on 26 Nov 2020
Moderna signs deal with EU for 160 million COVID-19 vaccine doses
26 November 2020 - The European Commission has signed a supply deal with Moderna which will see it secure an ...
Posted by Michael Wonder on 26 Nov 2020
FDA defers approval of daxibotulinumtoxinA for injection in glabellar lines due to COVID-19 related travel restrictions impacting manufacturing site inspection
25 November 2020 - Revance Therapeutics today announced that the United States FDA has deferred a decision on the biologics license ...
Posted by Michael Wonder on 26 Nov 2020
European Commission approves Janssen’s Tremfya (guselkumab), a first-in-class treatment for active psoriatic arthritis
25 November 2020 - Guselkumab is the first selective IL-23 p19 subunit inhibitor licensed for both the treatment of psoriatic arthritis ...
Posted by Michael Wonder on 26 Nov 2020
Bio-Thera Solutions submits marketing authorisation application for BAT1706, a proposed biosimilar to Avastin, to European Medicines Agency
25 November 2020 - Bio-Thera Solutions today announced that it has submitted the marketing authorisation application for BAT1706, a proposed biosimilar ...
Posted by Michael Wonder on 26 Nov 2020
Lynparza (olaparib) receives Health Canada approval for the treatment of BRCA or ATM gene-mutated metastatic castration-resistant prostate cancer
25 November 2020 - On 21 August 2020, Health Canada approved Lynparza (olaparib), for the treatment of adult patients with deleterious ...
Posted by Michael Wonder on 25 Nov 2020
FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow
25 November 2020 - On 24 November 2020, the FDA granted accelerated approval to naxitamab (Danyelza, Y-mAbs Therapeutics) in combination with ...
Posted by Michael Wonder on 25 Nov 2020
RhoVac's prostate cancer drug candidate RV001 is granted fast track designation by the FDA
25 November 2020 - RhoVac, a clinical stage company today announced that the American FDA has granted Fast Track Designation to ...
Posted by Michael Wonder on 25 Nov 2020
AstraZeneca gears up to vaccinate the world against COVID-19
24 November 2020 - Among the front-runners racing to deliver a COVID-19 shot, has the least vaccine experience. But it has ...