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RSS FeedPosted by Michael Wonder on 17 Feb 2022
Dr. Robert Califf returns as FDA's Commissioner
17 February 2022 - The Stakeholder Engagement Staff is pleased to announce the swearing in of Dr. Robert Califf this afternoon, ...
Posted by Michael Wonder on 17 Feb 2022
Agios wins FDA approval for pill to treat rare blood disease
17 February 2022 - The Cambridge company’s CEO says it has the potential to become a blockbuster drug. ...
Posted by Michael Wonder on 17 Feb 2022
Lupin announces FDA approval of supplemental new drug application for Solosec (secnidazole) in adolescents for both the treatment of bacterial vaginosis in females and trichomoniasis
17 February 2022 - Lupin Pharmaceuticals today announced that the U.S. FDA has approved the company's supplemental new drug application to ...
Posted by Michael Wonder on 17 Feb 2022
Health Canada authorises Novavax's Nuvaxovid COVID-19 vaccine
17 February 2022 - Today, Health Canada authorised Novavax's Nuvaxovid COVID-19 vaccine for the prevention of COVID-19 in adults 18 years ...
Posted by Michael Wonder on 17 Feb 2022
Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants
17 February 2022 - Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial ...
Posted by Michael Wonder on 17 Feb 2022
U.S. FDA accepts for priority review Bristol Myers Squibb’s supplemental biologics license application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
17 February 2022 - U.S. FDA has assigned a target action date of 24 June 2022. ...
Posted by Michael Wonder on 17 Feb 2022
COVID-19 vaccine weekly safety report (17 February 2022)
17 February 2022 - To 13 February 2022, the TGA has received 449 reports which have been assessed as likely to ...
Posted by Michael Wonder on 17 Feb 2022
FDA grants fast track designation to SBT101, the first investigational AAV based gene therapy for patients with adrenomyeloneuropathy
16 February 2022 - Initiation of Phase 1/2 clinical trial expected in the second half of 2022. ...
Posted by Michael Wonder on 17 Feb 2022
Empaveli approved by the TGA
17 February 2022 - First TGA approval for newcomer Apellis. ...
Posted by Michael Wonder on 16 Feb 2022
Moderna's COVID-19 vaccine (Spikevax) provisionally approved for use in individuals 6 years and older
17 February 2022 - The TGA has provisionally approved the Moderna COVID-19 vaccine, Spikevax, for use in individuals aged 6 ...
Posted by Michael Wonder on 16 Feb 2022
European Commission approves Oxbryta (voxelotor) for the treatment of haemolytic anaemia in patients with sickle cell disease age 12 years and older
16 February 2022 - The first sickle haemoglobin polymerisation inhibitor approved in Europe, Oxbryta increases haemoglobin levels and reduces sickling ...
Posted by Michael Wonder on 16 Feb 2022
Acadia Pharmaceuticals announces resubmission of supplemental new drug application to U.S. FDA for Nuplazid (pimavanserin) to treat Alzheimer’s disease psychosis
16 February 2022 - Acadia Pharmaceuticals announced today that it has resubmitted its supplemental new drug application for pimavanserin for ...
Posted by Michael Wonder on 16 Feb 2022
Merck struggles to win European approval for Covid antiviral pill
16 February 2022 - EMA said to be unlikely to grant marketing authorisation to molnupiravir this month after ‘problematic’ data. ...
Posted by Michael Wonder on 16 Feb 2022
Bonalive Biomaterials granted FDA breakthrough device designation for a bone graft substitute that potentially protects against microbial colonisation
16 February 2022 - The Center for Devices and Radiological Health at the U.S. FDA has determined that Bonalive Orthopedics granules, ...
Posted by Michael Wonder on 16 Feb 2022
Poxel announces FDA fast track status for PXL065 in X linked adrenoleukodystrophy
16 February 2022 - The initiation of the Phase IIa proof of concept clinical study for PXL065 in adrenoleukodystrophy is now ...