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RSS FeedPosted by Michael Wonder on 19 Apr 2022
iHealthScreen announces TGA approval for iPredict automated AI system for early diagnosis of diabetic retinopathy, age-related macular degeneration and glaucoma suspect
19 April 2022 - iHealthScreen is the first company in the USA to receive a CE certification, Australian Health approval, and ...
Posted by Michael Wonder on 19 Apr 2022
Aytu BioPharma announces fast track designation granted to AR101 for the treatment of vascular Ehlers-Danlos syndrome
19 April 2022 - Aytu BioPharma today announced that the U.S. FDA has granted fast track designation to AR101 (enzastaurin), a ...
Posted by Michael Wonder on 19 Apr 2022
Adicet Bio receives FDA fast track designation for lead candidate ADI-001
19 April 2022 - Adicet Bio today announced the U.S. FDA has granted fast track designation to its lead program ...
Posted by Michael Wonder on 19 Apr 2022
US Food and Drug Administration accepts new drug application for daprodustat
19 April 2022 - Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase 3 ...
Posted by Michael Wonder on 19 Apr 2022
EMA publishes agenda for 19-22 April 2022 CHMP meeting
19 April 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 19 Apr 2022
Enhertu granted priority review in the U.S. for patients with previously treated HER2 mutant metastatic non-small-cell lung cancer
19 April 2022 - Based on pivotal DESTINY-Lung01 results showing Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a 54.9% tumour response ...
Posted by Michael Wonder on 19 Apr 2022
Prescription medicines: applications under evaluation (April 2022)
19 April 2022 - The TGA has updated its list of applications for new medicines or new uses for existing medicines ...
Posted by Michael Wonder on 19 Apr 2022
Health Canada approves Keytruda (pembrolizumab) for the treatment of adult patients with high risk early stage triple negative breast cancer in combination with chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery
18 April 2022 - Approval Based on Data from Phase 3 KEYNOTE-522 Trial ...
Posted by Michael Wonder on 18 Apr 2022
Switzerland approves its first protein-based Covid vaccine
15 April 2022 - Swissmedic announced its approval on Wednesday making Nuvaxovid the first protein-based vaccine to be licensed in Switzerland. ...
Posted by Michael Wonder on 18 Apr 2022
FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies
18 April 2022 - Five years ago, the FDA launched a new program with the best of intentions: to speed ...
Posted by Michael Wonder on 15 Apr 2022
TG Therapeutics announces voluntary withdrawal of the BLA/sNDA for U2 to treat patients with CLL and SLL
15 April 2022 - TG Therapeutics today announced that the Company has voluntarily withdrawn the pending biologics license application/supplemental new drug ...
Posted by Michael Wonder on 15 Apr 2022
Evusheld receives Health Canada approval for pre-exposure prophylaxis (prevention) of COVID-19 in immune-compromised individuals
14 April 2022 - Evusheld is the first long-acting antibody combination to receive Health Canada authorisation for the prevention of ...
Posted by Michael Wonder on 14 Apr 2022
Merck announces US FDA has granted breakthrough therapy designation for V116, the Company’s investigational 21 valent Pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
14 April 2022 - V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged ...
Posted by Michael Wonder on 14 Apr 2022
U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...
Posted by Michael Wonder on 14 Apr 2022
COVID-19 vaccine weekly safety report (14 April 2022)
14 April 2022 - To 10 April 2022, the TGA has received 528 reports which have been assessed as likely to ...