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RSS FeedPosted by Michael Wonder on 16 Apr 2021
Lilly requests revocation of emergency use authorization for bamlanivimab alone to complete transition to bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.
16 April 2021 - Final step in Lilly's planned transition to provide only bamlanivimab and etesevimab together in the U.S. ...
Posted by Michael Wonder on 16 Apr 2021
Mayne Pharma and Mithra announce FDA approval of new oral contraceptive Estelle
15 April 2021 - Mayne Pharma Group and Mithra Pharmaceuticals are very pleased to announce that the US FDA has approved ...
Posted by Michael Wonder on 15 Apr 2021
EU drug regulator to issue view on J&J vaccine next week
15 April 2021 - Europe's drug regulator said on Wednesday it planned to issue a recommendation on Johnson & Johnson's ...
Posted by Michael Wonder on 15 Apr 2021
White House expands list of potential FDA Commissioners
14 April 2021 - Asian-American and Black doctors on short list of nominees to lead agency. ...
Posted by Michael Wonder on 15 Apr 2021
Perimeter Medical Imaging AI receives U.S. FDA breakthrough device designation for its optical coherence tomography imaging system with ImgAssist AI
15 April 2021 - New designation provides potential pathway to expedite adoption of Perimeter's transformative medical imaging technology combined with artificial ...
Posted by Michael Wonder on 15 Apr 2021
EMA starts review of VIR-7831 for treating patients with COVID-19
15 April 2021 - EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as ...
Posted by Michael Wonder on 15 Apr 2021
FibroGen receives rare paediatric disease designation from the U.S. FDA for pamrevlumab for the treatment of Duchenne muscular dystrophy
15 April 2021 - FibroGen announced that the U.S. FDA has granted rare paediatric disease designation for the company’s anti-CTGF antibody, ...
Posted by Michael Wonder on 15 Apr 2021
FDA wants more data on promising ALS drug, frustrating patients seeking faster access
15 April 2020 - People living with amyotrophic lateral sclerosis, or ALS, in the U.S. will have to wait longer ...
Posted by Michael Wonder on 15 Apr 2021
Health Canada stands by approval of AstraZeneca, Johnson & Johnson COVID-19 vaccines
14 April 2021 - Health Canada is standing by the approval of the Oxford-AstraZeneca and Johnson & Johnson vaccines for ...
Posted by Michael Wonder on 15 Apr 2021
Central Coast woman’s death after COVID-19 vaccine being investigated
15 April 2021 - Federal health authorities are investigating the death of a woman days after she received a COVID-19 ...
Posted by Michael Wonder on 15 Apr 2021
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) as first-line treatment for patients with advanced renal cell carcinoma
14 April 2021 - Approval based on Phase 3 CheckMate-9ER trial results showing Opdivo in combination with Cabometyx significantly improved overall ...
Posted by Michael Wonder on 14 Apr 2021
PhRMA's three part approach to build a better health care system
13 April 2021 - Our plan is based on three key pillars: ending the pandemic and building a more resilient system, ...
Posted by Michael Wonder on 14 Apr 2021
New blow to rollout as Novavax Covid-19 vaccine hits supply hiccup
15 April 2021 - Australia’s vaccine rollout has been dealt another blow as Novavax confirms manufacturing supply shortages mean it ...
Posted by Michael Wonder on 14 Apr 2021
Europe bets heavily on Pfizer in vaccine strategy overhaul
15 April 2021 - Europe has hinted it will not renew contracts for coronavirus vaccines produced by pharmaceutical giants AstraZeneca ...
Posted by Michael Wonder on 14 Apr 2021
Novavax COVID-19 vaccine in Australia: When will we get it? And is it better than Pfizer?
14 April 2021 - Australia's sluggish vaccine rollout was last week thrown another curve ball, with new medical advice recommending ...