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RSS FeedPosted 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 06 Sep 2024
Sun Pharma and Moebius Medical announce fast track designation granted for MM-II for the treatment of osteoarthritis knee pain
6 September 2024 - Sun Pharma and Moebius Medical announced that the US FDA has granted fast track designation to ...
Posted by Michael Wonder on 06 Sep 2024
Azurity Pharmaceuticals announces FDA approval of Nymalize (nimodipine) oral solution 30 mg/5 mL pre-filled ENFit syringe
3 September 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Nymalize (nimodipine) oral solution in a 30 ...
Posted by Michael Wonder on 06 Sep 2024
EMA Committee for Medicinal Products for Human Use adopts positive opinion recommending authorisation of Moderna's COVID-19 mRNA vaccine targeting the SARS-COV-2 variant JN.1
5 September 2024 - Moderna's updated COVID-19 mRNA vaccine will be available for the 2024-2025 vaccination season, pending a European ...
Posted by Michael Wonder on 06 Sep 2024
Advanz Pharma secures temporary suspension of the European Commission decision on the Ocaliva conditional marketing authorisation in Europe
5 September 2024 - Advanz Pharma today announces that the General Court of the European Union has temporarily suspended the European ...
Posted by Michael Wonder on 06 Sep 2024
Travere Therapeutics announces full FDA approval of Filspari (sparsentan), the only non-immunosuppressive treatment that significantly slows kidney function decline in IgA nephropathy
5 September 2024 - Conversion to full approval based on results from the PROTECT study, where Filspari delivered superior long-term kidney ...
Posted by Michael Wonder on 05 Sep 2024
Breakthrough therapy designation for Sanbexin sublingual tablets granted by the US FDA
5 September 2024 - On 2 September 2024, Simcere Pharmaceuticals announced that Sanbexin sublingual tablets (edaravone and dexborneol sublingual tablets), an ...
Posted by Michael Wonder on 05 Sep 2024
Perspective Therapeutics granted fast track designation for VMT01 for the diagnosis and treatment of MC1R positive melanoma
5 September 2024 - Perspective Therapeutics today announced that the US FDA granted fast track designation for the development of ...
Posted by Michael Wonder on 05 Sep 2024
US FDA approves FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for Lynparza (olaparib) in combination with abiraterone for patients with BRCA mutated metastatic castration-resistant prostate cancer
3 September 2024 - Foundation Medicine’s tissue and liquid biopsy tests can now be used to identify more patients who could ...
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 05 Sep 2024
Breakthrough therapies approved based on surrogate endpoints often lack post-marketing requirements
4 September 2024 - The use of surrogate markers to support drug approvals without requiring postmarketing studies can “hinder accurate ...
Posted by Michael Wonder on 05 Sep 2024
Synthekine granted US FDA fast track designation for CD19 CAR-T and orthogonal IL-2 investigational therapy, SYNCAR-001 + STK-009, for the treatment of lupus without lymphodepletion
4 September 2024 - Synthekine today announced that the US FDA has granted fast track designation to SYNCAR-001 + STK-009, ...
Posted by Michael Wonder on 05 Sep 2024
Winrevair (sotatercept) is now authorised for use in Canada for adults with pulmonary arterial hypertension
4 September 2024 - Merck announced that Winrevair (sotatercept) is now authorised for use in Canada in combination with standard ...