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RSS FeedPosted by Michael Wonder on 02 Nov 2024
Alvotech and Teva announce US FDA approval of additional presentation of Selarsdi (ustekinumab-aekn), expanding its label to include further indications approved for reference product, Stelara (ustekinumab)
22 October 2024 - Approval of Selarsdi 130 mg/26 mL in a single dose vial for intravenous infusion expands label to ...
Posted by Michael Wonder on 01 Nov 2024
FELIQS receives US FDA fast track designation for FLQ-101, a first in class small molecule to prevent retinopathy of prematurity
1 November 2024 - FELIQS announced today that the US FDA has granted its lead asset, FLQ-101, fast track designation for ...
Posted by Michael Wonder on 01 Nov 2024
Eisai completes rolling submission to US FDA for Leqembi (lecanemab-irmb) biologics license application for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease under the fast track status
31 October 2024 - Eisai and Biogen announced today that Eisai has completed the rolling submission of a biologics license application ...
Posted by Michael Wonder on 31 Oct 2024
Verastem Oncology completes rolling NDA submission to the FDA for avutometinib plus defactinib as a treatment for recurrent KRAS mutant low grade serous ovarian cancer
31 October 2024 - Company seeking accelerated approval and priority review of its new drug application submission in patients with KRAS ...
Posted by Michael Wonder on 31 Oct 2024
PTC Therapeutics announces FDA acceptance of Translarna NDA resubmission
30 October 2024 - PTC Therapeutics announced today the US FDA has accepted for review the resubmission of the new drug ...
Posted by Michael Wonder on 31 Oct 2024
Foresee Pharmaceuticals announces submission of the NDA to the US FDA for the 3 month version of Camcevi for the treatment of advanced prostate cancer
30 October 2024 - Foresee Pharmaceuticals announced today that it has submitted a 505(b)(2) new drug application for the 3 month ...
Posted by Michael Wonder on 30 Oct 2024
US FDA grants Prolong Pharmaceuticals FDA fast track designation for novel stroke therapy (PP-007) in HEMERA-1 clinical study
30 October 2024 - Prolong Pharmaceuticals announced today that its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), has received fast track designation ...
Posted by Michael Wonder on 29 Oct 2024
FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukaemia
29 October 2024 - Today, the FDA granted accelerated approval to asciminib (Scemblix, Novartis) for adult patients with newly diagnosed ...
Posted by Michael Wonder on 26 Oct 2024
FDA grants rare paediatric disease designation to Omeros’ MASP-3 inhibitor zaltenibart for treatment of C3 glomerulopathy
24 October 2024 - Phase 3 studies on the horizon in both PNH and C3G. ...
Posted by Michael Wonder on 26 Oct 2024
Iterum Therapeutics receives US FDA approval of Orlynvah (oral sulopenem) for the treatment of uncomplicated urinary tract infections
25 October 2024 - Orlynvah is the first oral penem approved for use in the US and the second FDA approved ...
Posted by Michael Wonder on 26 Oct 2024
Lenz Therapeutics announces FDA acceptance of new drug application for LNZ100 for the treatment of presbyopia
21 October 2024 - FDA sets PDUFA target date of 8 August 2025. ...
Posted by Michael Wonder on 25 Oct 2024
Shionogi receives US FDA fast track designation for the novel anti-respiratory syncytial virus drug candidate S-337395
24 October 2024 - Shionogi announced that the US FDA has granted fast track designation for S-337395, our novel anti-respiratory syncytial ...
Posted by Michael Wonder on 24 Oct 2024
HiberCell receives FDA fast track designation for HC-7366 for the treatment of relapsed or refractory acute myeloid leukaemia
23 October 2024 - HiberCell is pleased to announce that the US FDA has granted fast track designation to HC-7366 for ...
Posted by Michael Wonder on 23 Oct 2024
Cothera Bioscience announces FDA fast track designation for clinical program PC-002
14 October 2024 - Cothera Bioscience is pleased to announce that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 22 Oct 2024
Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly
22 October 2024 - The FDA issues a complete response letter for CAM2029 pending FDA’s assessment of responses from a third ...