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RSS FeedPosted by Michael Wonder on 25 Jan 2022
Magnesium Development Company announces FDA breakthrough device designation for resorbable HC screw
24 January 2022 - Magnesium Development Company's fixation solution, the HC Screw, has received the FDA’s breakthrough device designation, having exceeded ...
Posted by Michael Wonder on 25 Jan 2022
Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant
24 January 2022 - In light of the most recent information and data available, today, the FDA revised the authorizations ...
Posted by Michael Wonder on 24 Jan 2022
FDA approves Nucala (mepolizumab) 40 mg pre-filled syringe for children with severe eosinophilic asthma
24 January 2022 - This approval allows for at home administration in patients 6-11 years old with severe eosinophilic asthma. ...
Posted by Michael Wonder on 24 Jan 2022
Cook Medical receives FDA breakthrough designation for new drug eluting stent
21 January 2022 - Cook Medical has received breakthrough device designation from the US FDA on a new drug eluting stent ...
Posted by Michael Wonder on 24 Jan 2022
Codexis announces FDA orphan drug and rare paediatric disease designations for CDX-6512 for the treatment of homocystinuria
24 January 2022 - Codexis today announced that the U.S. FDA has granted the company orphan drug designation for CDX-6512 for ...
Posted by Michael Wonder on 24 Jan 2022
Health Canada approves Ipsen’s Sohonos (palovarotene) as the first approved treatment for fibrodysplasia ossificans progressiva
24 January 2022 - Ipsen today announced the Health Canada approval of Sohonos (palovarotene), an oral selective retinoic-acid receptor gamma agonist ...
Posted by Michael Wonder on 24 Jan 2022
Merck provides US and Japan regulatory update for gefapixant
24 January 2022 - Merck today announced that the US FDA has issued a complete response letter regarding Merck’s new drug ...
Posted by Michael Wonder on 24 Jan 2022
EMA publishes agenda for 24-27 Jan CHMP meeting
23 January 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 24 Jan 2022
TGA approves MSD's Vaxneuvance
24 January 2022 - Vaxneuvance (pneumococcal 15 valent conjugate vaccine (CRM197 protein)) was approved on 17 January 2022 for active ...
Posted by Michael Wonder on 24 Jan 2022
FDA considers limiting authorisation of certain monoclonal antibody treatments
23 January 2022 - Federal regulators are considering limiting the authorisation of certain monoclonal antibody treatments that have not proved ...
Posted by Michael Wonder on 23 Jan 2022
ATAGI statement on the use of Novavax COVID-19 vaccine (Nuvaxovid)
24 January 2022 - ATAGI recommends that Novavax COVID-19 vaccine can be used for the primary course of COVID-19 vaccination ...
Posted by Michael Wonder on 22 Jan 2022
COVID-19 vaccines and treatments: we must have raw data, now
19 January 2022 - Data should be fully and immediately available for public scrutiny ...
Posted by Michael Wonder on 22 Jan 2022
Patent thickets are thwarting U.S. availability of lower cost biosimilar medicines, study finds
18 January 2022 - Amid debate over competition in the pharmaceutical industry, a new analysis found just 6% of patents ...
Posted by Michael Wonder on 22 Jan 2022
FDA takes actions to expand use of treatment for outpatients with mild to moderate COVID-19
21 January 2022 - Today, the U.S. FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) ...
Posted by Michael Wonder on 21 Jan 2022
Pfizer and OPKO provide update on the biologics license application for somatrogon for paediatric growth hormone deficiency
21 January 2022 - Pfizer and OPKO Health announced today that the U.S. FDA issued a complete response letter for the ...