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RSS FeedPosted by Michael Wonder on 06 Oct 2023
Coherus announces resubmission of biologics license application supplement for Udenyca Onbody
5 October 2023 - Resubmission follows the satisfactory resolution of the FDA’s review of inspection findings at the third-party filler. ...
Posted by Michael Wonder on 04 Oct 2023
Galderma announces progress with relabotulinumtoxinA regulatory submissions
2 October 2023 - Galderma receives FDA complete response letter with comments isolated to Chemistry, Manufacturing, and Controls items. ...
Posted by Michael Wonder on 03 Oct 2023
Rocket Pharmaceuticals announces FDA acceptance of biologics license application with priority review for RP-L201 (marnetegragene autotemcel) for the treatment of severe leukocyte adhesion deficiency-I
2 October 2023 - PDUFA target action date is 31 March 2024. ...
Posted by Michael Wonder on 02 Oct 2023
US FDA issues complete response letter for lebrikizumab based on inspection findings at third party manufacturer
2 October 2023 - In the letter, the FDA stated no concerns about the clinical data package, safety or label ...
Posted by Michael Wonder on 29 Sep 2023
Odronextamab BLA for treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma accepted for FDA priority review
29 September 2023 - If approved, odronextamab would be the first and only bispecific antibody approved in both FL and DLBCL ...
Posted by Michael Wonder on 29 Sep 2023
Karuna Therapeutics submits new drug application to US FDA for KarXT for the treatment of schizophrenia
28 September 2023 - KarXT, a dual M1/M4 muscarinic agonist, represents the first new mechanism of action to treat schizophrenia in ...
Posted by Michael Wonder on 29 Sep 2023
Merck receives priority review from FDA for new biologics license application for sotatercept, an activin signaling inhibitor to treat adults with pulmonary arterial hypertension
28 September 2023 - Application based on clinically meaningful results from the Phase 3 STELLAR trial. ...
Posted by Michael Wonder on 29 Sep 2023
Appili Therapeutics announces US FDA approval of Likmez (ATI-1501) metronidazole oral suspension
25 September 2023 - Currently Likmez is the only liquid oral suspension of metronidazole approved in the US. ...
Posted by Michael Wonder on 28 Sep 2023
Akebia Therapeutics resubmits new drug application to the FDA for vadadustat
28 September 2023 - Akebia Therapeutics today announced it has resubmitted its new drug application to the US FDA for ...
Posted by Michael Wonder on 28 Sep 2023
Alpha Cognition announces submission of new drug application to the FDA for ALPHA-1062 for mild to moderate Alzheimer’s disease
27 September 2023 - Alpha Cognition is pleased to announce the submission of a new drug application to the US FDA ...
Posted by Michael Wonder on 28 Sep 2023
Botanix Pharmaceuticals suffers setback in FDA approval for sofpironium bromide gel to treat hyperhidrosis
26 September 2023 - Botanix Pharmaceuticals has had its application to use the novel sofpironium bromide gel to treat primary ...
Posted by Michael Wonder on 27 Sep 2023
FDA accepts submission to add PH-ILD to Yutrepia label
26 September 2023 - Sets PDUFA goal date of 24 January 2024. ...
Posted by Michael Wonder on 26 Sep 2023
Abeona Therapeutics submits biologics license application to US FDA seeking priority review and approval of EB-101 for the treatment of patients with recessive dystrophic epidermolysis bullosa
26 September 2023 - Abeona Therapeutics today announced the Company has submitted a biologics license application to the US FDA seeking ...
Posted by Michael Wonder on 25 Sep 2023
FDA issues complete response letter for Udencya Onbody biologics license application solely due to an on-going review of inspection findings at a third-party filler
25 September 2023 - No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or ...
Posted by Michael Wonder on 25 Sep 2023
Theratechnologies submits tesamorelin F8 formulation sBLA for FDA review
25 September 2023 - Theratechnologies today announced that the Company has filed a supplemental biologics license application for the F8 formulation ...