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RSS FeedPosted by Michael Wonder on 04 May 2021
Clearside Biomedical announces resubmission of new drug application for Xipere for treatment of macular oedema associated with uveitis
3 May 2021 - Clearside Biomedical announced today the resubmission of its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 03 May 2021
Intra-Cellular Therapies announces FDA acceptance of Caplyta (lumateperone) sNDAs for the treatment of bipolar depression
3 May 2021 - Intra-Cellular Therapies today announced that the U.S. FDA has accepted for review its supplemental new drug applications ...
Posted by Michael Wonder on 03 May 2021
Hutchmed completes rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
3 May 2021 - First NDA submission by Hutchmed in the U.S.; product launch preparations underway. ...
Posted by Michael Wonder on 30 Apr 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for patients with muscle-invasive urothelial carcinoma
30 April 2021 - Application based on Phase 3 CheckMate-274 trial, in which Opdivo nearly doubled disease-free survival compared to placebo. ...
Posted by Michael Wonder on 30 Apr 2021
Update on U.S. FDA review of LEO Pharma’s biologics license application for tralokinumab for the treatment of adults with moderate to severe atopic dermatitis
29 April 2021 - FDA has requested additional data relating to a device component of tralokinumab. ...
Posted by Michael Wonder on 29 Apr 2021
Biogen provides regulatory update on the supplemental biologic license application for subcutaneous administration of Tysabri (natalizumab)
28 April 2021 - Biogen today announced that it has received a complete response letter from the U.S. FDA for ...
Posted by Michael Wonder on 28 Apr 2021
FDA grants priority review for Nefecon for patients with IgA nephropathy
28 April 2021 - Calliditas Therapeutics today announced that the U.S. FDA has accepted the submission and granted priority review for ...
Posted by Michael Wonder on 28 Apr 2021
FDA begins review of GC Pharma’s blood product for marketing authorisation
27 April 2021 - The U.S. FDA has entered a full review of GC Pharma’s intravenous immunoglobulin therapy GC5107 for ...
Posted by Michael Wonder on 28 Apr 2021
Takeda announces U.S. FDA grants priority review for new drug application for mobocertinib (TAK-788) as a treatment for EGFR exon 20 insertion positive metastatic non-small cell lung cancer
28 April 2021 - Prescription Drug User Fee Act target action date set for 26 October 2021. ...
Posted by Michael Wonder on 27 Apr 2021
Sol-Gel Technologies provides update on FDA review of Epsolay
27 April 2021 - Sol-Gel Technologies today announced an update regarding the U.S. FDA approval process for Epsolay (benzoyl peroxide) ...
Posted by Michael Wonder on 27 Apr 2021
Enzyvant resubmits biologics licence application to FDA for RVT-802 for paediatric congenital athymia
27 April 2021 - Enzyvant today announced the resubmission of the biologics licence application to the U.S. FDA for RVT-802, ...
Posted by Michael Wonder on 27 Apr 2021
Reata announces FDA accepted for filing the NDA for bardoxolone for the treatment of patients with chronic kidney disease caused by Alport syndrome
26 April 2021 - Application assigned a PDUFA date of 25 February 2022. ...
Posted by Michael Wonder on 26 Apr 2021
Axsome Therapeutics announces FDA acceptance and priority review of new drug application for AXS-05 for treatment of major depressive disorder
26 April 2021 - FDA grants priority review and sets PDUFA action goal date of 22 August 2021. ...
Posted by Michael Wonder on 20 Apr 2021
Biocartis announces US FDA 510(k) submission of its Idylla MSI test
20 April 2021 - First US FDA oncology assay submission for Biocartis. ...
Posted by Michael Wonder on 20 Apr 2021
Alnylam submits new drug application with U.S. FDA for vutrisiran for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults
19 April 2021 - Alnylam has submitted a new drug application to the U.S. FDA for the approval of vutrisiran for ...