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RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 30 Mar 2022
Akebia Therapeutics receives complete response letter from the FDA for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients
30 March 2022 - Akebia Therapeutics today announced that the U.S. FDA has issued a complete response letter to Akebia's ...
Posted by Michael Wonder on 30 Mar 2022
ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for virologically suppressed adolescents living with HIV who are 12 years of age or older and weigh at least 35 kg
29 March 2022 - The expanded indication for the first and only complete long-acting HIV regimen provides an option with as ...
Posted by Michael Wonder on 30 Mar 2022
EMA starts rolling review of COVID-19 vaccine HIPRA (PHH-1V)
29 March 2022 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine HIPRA (also known as PHH-1V). ...
Posted by Michael Wonder on 30 Mar 2022
Enanta Pharmaceuticals receives FDA fast track designation for EDP-235, its oral 3CL protease inhibitor specifically designed for the treatment and prevention of COVID-19
29 March 2022 - Enanta Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for EDP-235, its ...
Posted by Michael Wonder on 30 Mar 2022
Tagraxofusp for treating blastic plasmacytoid dendritic cell neoplasm
30 March 2022 - Tagraxofusp is human interleukin-3 genetically conjugated to diphtheria toxin protein. ...
Posted by Michael Wonder on 30 Mar 2022
MSAC publishes agenda for July 2022 meeting
30 March 2022 - 12 agenda items for consideration at the 28-29 July 2022 meeting. ...
Posted by Michael Wonder on 30 Mar 2022
ImmunoGen submits biologics license application to the US Food and Drug Administration for mirvetuximab soravtansine in ovarian cancer
29 March 2022 - Submission based on positive results from pivotal Phase 3 SORAYA trial. ...
Posted by Michael Wonder on 30 Mar 2022
Government hopes to hook voters with cheaper drugs
29 March 2022 - Patients will get access to cheaper or free medicines sooner under plans to reduce the PBS ...
Posted by Michael Wonder on 30 Mar 2022
Drug trials a ‘ticking time bomb’: ex-TGA agent
28 March 2022 - A former TGA official who led the regulator’s inspections program has warned that a lack of ...
Posted by Michael Wonder on 30 Mar 2022
Cystic fibrosis: early access granted to the Kaftrio/Kalydeco combination
29 March 2022 - The High Authority for Health has authorised early access to a first treatment for children aged 6 ...
Posted by Michael Wonder on 29 Mar 2022
FDA authorises second booster dose of two COVID-19 vaccines for older and immunocompromised individuals
29 March 2022 - Today, the U.S. FDA authorised a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 ...
Posted by Michael Wonder on 29 Mar 2022
Nurix Therapeutics awarded Innovation Passport for entry into Innovative Licensing and Access Pathway in the United Kingdom for NX-1607
29 March 2022 - NX-1607 is being evaluated in multiple immuno-oncology indications, including a range of solid tumour types. ...
Posted by Michael Wonder on 29 Mar 2022
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for resectable non-small-cell lung cancer
29 March 2022 - Application based on CheckMate-816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete ...
Posted by Michael Wonder on 29 Mar 2022
Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA
29 March 2022 - Priority review granted by U.S. FDA. ...
Posted by Michael Wonder on 29 Mar 2022
Federal budget 2022: more funding for breast cancer drug Trodelvy
29 March 2022 - Against all the odds Sydney mum Alison Day will get to celebrate her daughter’s 12th birthday — ...