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RSS FeedPosted by Michael Wonder on 23 Apr 2022
Highlights from the 19-22 April 2022 CHMP meeting
22 April 2022 - The EMA’s CHMP recommended four medicines for approval in the European Union at its April 2022 ...
Posted by Michael Wonder on 23 Apr 2022
Medexus Pharmaceuticals announces resubmission of treosulfan NDA
22 April 2022 - Additional data collection and analysis reconfirms confidence in new drug application for treosulfan. ...
Posted by Michael Wonder on 23 Apr 2022
Quanterix granted breakthrough device designation from U.S. FDA for NfL test for multiple sclerosis
22 April 2022 - Blood based assay has the potential to serve the multiple sclerosis community in management of relapsing-remitting form ...
Posted by Michael Wonder on 21 Apr 2022
Bridge to Life receives breakthrough device designation from the FDA
21 April 2022 - Bridge to Life advances their perfusion system development with the breakthrough device designation for the LifeCradle ...
Posted by Michael Wonder on 21 Apr 2022
Will the shadow of Aduhelm cloud FDA’s decision-making on an ALS therapy?
21 April 2022 - On March 30, an FDA advisory panel voted 6 to 4 against recommending approval of what ...
Posted by Michael Wonder on 21 Apr 2022
What counts as a breakthrough? 8 insights on the FDA’s approach to medical devices.
21 April 2022 - The word breakthrough carries a kind of weight: it’s a dramatic step forward, a critical advance in ...
Posted by Michael Wonder on 21 Apr 2022
Revance receives FDA acceptance of BLA resubmission for daxibotulinumtoxinA for injection for glabellar lines
21 April 2022 - PDUFA goal date set for 8 September 2022. ...
Posted by Michael Wonder on 21 Apr 2022
Zambon receives U.S. FDA breakthrough therapy designation for CMS I-neb in patients with non-cystic fibrosis bronchiectasis
21 April 2022 - CMS I-neb is an investigational treatment being developed as a potential first-in-class inhaled therapy for adult patients ...
Posted by Michael Wonder on 21 Apr 2022
COVID-19 vaccine weekly safety report (24 April 2022)
24 April 2022 - To 17 April 2022, the TGA has received 534 reports which have been assessed as likely to ...
Posted by Michael Wonder on 20 Apr 2022
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 years with at least one F508del mutation
20 April 2022 - Vertex has submitted this indication to CADTH & INESSS for health technology assessments. ...
Posted by Michael Wonder on 20 Apr 2022
Otsuka announces Health Canada approval of Tavneos (avacopan) for ANCA associated vasculitis
20 April 2022 - Launch is expected in Canada in the fourth quarter of 2022. ...
Posted by Michael Wonder on 20 Apr 2022
Extrapolation of drug indications from study populations by FDA is ‘common’
19 April 2022 - Extrapolation of indications in new drug approvals by the U.S. FDA to populations not originally studied ...
Posted by Michael Wonder on 20 Apr 2022
New drug application resubmission update
20 April 2022 - Polarean Imaging announces that further to the RNS issued on 31 March 2022, the Company can confirm ...
Posted by Michael Wonder on 20 Apr 2022
FDA grants regenerative medicine advanced therapy designation to AlloVir’s posoleucel for prevention of multiple life-threatening infections from six viruses in allogeneic haematopoietic cell transplant patients
20 April 2022 - Posoleucel’s third regenerative medicine advanced therapy designation marks an unprecedented regulatory distinction among cell and gene therapies. ...
Posted by Michael Wonder on 20 Apr 2022
Teva and MedinCell receive complete response letter for TV-46000/mdc-IRM
19 April 2022 - Teva Pharmaceuticals and MedinCell announced that the U.S. FDA has issued a complete response letter regarding the ...