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RSS FeedPosted by Michael Wonder on 01 Oct 2024
Enhertu granted priority review in the US for patients with HER2 low or HER2 ultra-low metastatic breast cancer who have received at least one line of endocrine therapy
1 October 2024 - Based on DESTINY-Breast06 phase 3 trial which demonstrated a statistically significant and clinically meaningful progression-free survival ...
Posted by Michael Wonder on 29 Sep 2024
AbbVie submits biologics license application to the FDA for telisotuzumab vedotin in previously treated non-small cell lung cancer
27 September 2024 - Biologics license application submission for accelerated approval is supported by data from the Phase 2 LUMINOSITY trial ...
Posted by Michael Wonder on 28 Sep 2024
Bayer submits supplemental new drug application to US FDA seeking expanded indication for Nubeqa (darolutamide) in metastatic hormone-sensitive prostate cancer
26 September 2024 - Submission is based on positive results from the investigational pivotal Phase 3 ARANOTE trial that showed Nubeqa ...
Posted by Michael Wonder on 25 Sep 2024
FDA accepts Arcutis’ supplemental new drug application for Zoryve (roflumilast) foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over
24 September 2024 - US FDA has set a PDUFA target action date of 22 May 2025. ...
Posted by Michael Wonder on 24 Sep 2024
Elevar Therapeutics resubmits new drug application to FDA for combination of camrelizumab plus rivoceranib as first-line treatment option for unresectable hepatocellular carcinoma boosted by CARES-310 leading overall survival analysis
23 September 2024 - Elevar Therapeutics today announced the resubmission of a new drug application to the US FDA for its ...
Posted by Michael Wonder on 24 Sep 2024
FDA accepts Leo Pharma’s filing of delgocitinib cream new drug application for the treatment of chronic hand eczema
23 September 2024 - The application has been accepted for filing and, if approved, delgocitinib cream would become the first treatment ...
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
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 ...