Blog
RSS FeedPosted by Michael Wonder on 19 Sep 2024
Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada
18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 18 Sep 2024
Biogen's new drug submission for omaveloxolone accepted for priority review by Health Canada for the treatment of Friedreich's ataxia
17 September 2024 - If approved, omaveloxolone would be the only disease specific treatment option for patients living with this progressive ...
Posted by Michael Wonder on 13 Sep 2024
Johnson & Johnson seeks first EU approval of nipocalimab to treat a broad population of patients living with antibody-positive generalised myasthenia gravis
12 September 2024 - Janssen-Cilag today announced the submission of the marketing authorisation application to the EMA) seeking first approval ...
Posted by Michael Wonder on 11 Sep 2024
ARS Pharmaceuticals submits sNDA to FDA for neffy 1 mg dose for paediatric patients with type I allergic reactions who weigh 15 to 30 kg (33-66 lbs)
9 September 2024 - ARS Pharmaceuticals announced today the submission of a supplemental new drug application for neffy 1 mg ...
Posted by Michael Wonder on 07 Sep 2024
Axogen completes submission of biologics license application to US FDA for Avance Nerve Graft
6 September 2024 - Axogen announced that it has completed the rolling submission process for its biologics license application to the ...
Posted by Michael Wonder on 07 Sep 2024
KalVista announces FDA acceptance of new drug application for sebetralstat for oral on-demand treatment of hereditary angioedema
3 September 2024 - FDA PDUFA goal date of 17 June 2025. ...
Posted by Michael Wonder on 05 Sep 2024
Prilenia’s pridopidine for Huntington’s disease accepted for European marketing authorisation review
3 September 2024 - Prilenia Therapeutics announces the acceptance of its European marketing authorisation application for pridopidine (45 mg orally ...
Posted by Michael Wonder on 05 Sep 2024
Axsome Therapeutics announces FDA acceptance of NDA resubmission for AXS-07 for the acute treatment of migraine
4 September 2024 - Axsome Therapeutics today announced that the US FDA has acknowledged the resubmission of the Company’s new drug ...
Posted by Michael Wonder on 04 Sep 2024
Unicycive Therapeutics announces submission of the new drug application to the US FDA for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis
3 September 2024 - Unicycive Therapeutics today announced that the Company has submitted a new drug application to the US FDA ...
Posted by Michael Wonder on 29 Aug 2024
Johnson & Johnson seeks first approval of nipocalimab to treat broadest population living with antibody positive generalised myasthenia gravis
29 August 2024 - Filing based on the Phase 3 Vivacity-MG3 program, the first-and-only study results in the class demonstrating sustained ...
Posted by Michael Wonder on 29 Aug 2024
FDA grants priority review to SpringWorks Therapeutics’ new drug application for mirdametinib for the treatment of adults and children with neurofibromatosis type 1-associated plexiform neurofibromas
28 August 2024 - PDUFA target action date of 28 February 2025. ...
Posted by Michael Wonder on 28 Aug 2024
Telix submits NDA for TLX101-CDx (Pixclara) brain cancer imaging agent
28 August 2024 - Telix today announces it has submitted a new drug application to the US FDA for TLX101-CDx, (Pixclara, ...
Posted by Michael Wonder on 27 Aug 2024
Soleno Therapeutics announces US FDA acceptance for filing and priority review of NDA for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
27 August 2024 - Soleno Therapeutics today announced that the US FDA has accepted for filing its new drug application ...
Posted by Michael Wonder on 27 Aug 2024
Rhythm Pharmaceuticals announces FDA acceptance for priority review of supplemental new drug application for Imcivree (setmelanotide) in patients as young as 2 years old
26 August 2024 - FDA sets PDUFA goal date of 26 December 2024. ...
Posted by Michael Wonder on 21 Aug 2024
Bristol Myers Squibb receives US Food and Drug Administration sBLA acceptance for first-line treatment of unresectable hepatocellular carcinoma
21 August 2024 - The US FDA assigned a target action date of 21 April 2025. ...