Blog
RSS FeedPosted by Michael Wonder on 01 Jun 2021
Alkermes announces FDA approval of Lybalvi for the treatment of schizophrenia and bipolar I disorder
1 June 2021 - Commercial launch planned for fourth quarter 2021. ...
Posted by Michael Wonder on 01 Jun 2021
Akebia and Otsuka announce FDA acceptance for filing of new drug application for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis and not on dialysis
1 June 2021 - Vadadustat assigned PDUFA target action date of 29 March 2022. ...
Posted by Michael Wonder on 01 Jun 2021
BeyondSpring announces U.S. FDA acceptance and priority review of new drug application for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia
1 June 2021 - The FDA has set a Prescription Drug User Fee Act target action date for 30 November 2021. ...
Posted by Michael Wonder on 01 Jun 2021
EMA and EUnetHTA take stock of their co-operation
1 June 2021 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) have published a report on ...
Posted by Michael Wonder on 01 Jun 2021
Health Canada approves Abecma (idecabtagene vicleucel), the first and only anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma
31 May 2021 - Abecma is the first personalised cell therapy available to Canadian patients for the treatment of adults ...
Posted by Michael Wonder on 31 May 2021
Suspend intellectual property rights for COVID-19 vaccines
28 May 2021 - Waivers are essential for global vaccine equity ...
Posted by Michael Wonder on 31 May 2021
Eton Pharmaceuticals receives complete response letter from U.S. FDA for dehydrated alcohol injection
28 May 2021 - Eton Pharmaceuticals today announced that the company has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 31 May 2021
If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it
30 May 2021 - Most visits to the memory centre where I care for individuals living with Alzheimer’s disease end ...
Posted by Michael Wonder on 31 May 2021
FDA grants breakthrough device designation for smart orthopaedic implants
28 May 2021 - Intelligent Implants has announced today that its SmartFuse system has received breakthrough device designation by the ...
Posted by Michael Wonder on 30 May 2021
Diurnal receives European Commission approval for Efmody
28 May 2021 - Commercial launch anticipated in Q3 2021. ...
Posted by Michael Wonder on 30 May 2021
Calliditas announces submission of marketing authorisation application for Nefecon to the European Medicines Agency
28 May 2021 - Calliditas Therapeutics today announced that the company submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 29 May 2021
Ipsen confirms U.S. FDA accepts new drug application for palovarotene as the first potential treatment worldwide for fibrodysplasia ossificans progressiva
28 May 2021 - New drug application granted priority review status, with a decision anticipated on 30 November 2021. ...
Posted by Michael Wonder on 28 May 2021
FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma
28 May 2021 - Today, the FDA granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics), a kinase inhibitor for adults ...
Posted by Michael Wonder on 28 May 2021
First COVID-19 vaccine approved for children aged 12 to 15 in EU
28 May 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
Posted by Michael Wonder on 28 May 2021
FDA approves first targeted therapy for lung cancer mutation previously considered resistant to drug therapy
28 May 2021 - Today, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients ...