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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
US will still pay at least twice as much after negotiating drug prices
3 September 2024 - The US Government's first ever negotiated prices for prescription drugs are still on average more than ...
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 06 Sep 2024
ICER publishes evidence report on treatments for transthyretin amyloid cardiomyopathy
5 September 2024 - Current evidence suggests that tafamidis and acoramidis provide a net health benefit when compared to no ...
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
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
Innovent receives fast track designation from the US FDA for IBI363 (PD-1/IL-2α bispecific antibody fusion protein) as monotherapy for advanced melanoma
4 September 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its PD-1/IL-2α bispecific antibody ...
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 ...