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RSS FeedPosted by Michael Wonder on 16 Oct 2023
Tagrisso plus chemotherapy granted priority review in the US for patients with EGFR mutated advanced lung cancer
16 October 2023 - Decision based on FLAURA2 Phase 3 trial results which extended median progression-free survival by nearly 9 ...
Posted by Michael Wonder on 14 Oct 2023
Catalyst Pharmaceuticals announces FDA acceptance of the supplemental new drug application for Firdapse
13 October 2023 - US FDA assigned target action date of 4 June 2024. ...
Posted by Michael Wonder on 13 Oct 2023
Supernus resubmits NDA for SPN-830 apomorphine infusion device
9 October 2023 - Supernus Pharmaceuticals today announced it has resubmitted its new drug application for its apomorphine infusion device ...
Posted by Michael Wonder on 12 Oct 2023
Alvotech provides update on status of US biologics license application for AVT04
12 October 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics ...
Posted by Michael Wonder on 09 Oct 2023
Alnylam announces receipt of complete response letter from US FDA for supplemental new drug application for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis
9 October 2023 - FDA cites insufficient evidence of clinical meaningfulness. ...
Posted by Michael Wonder on 08 Oct 2023
Sun Pharma announces US FDA filing acceptance of new drug application for deuruxolitinib
6 October 2023 - Deuruxolitinib is being evaluated for treatment of moderate to severe alopecia areata. ...
Posted by Michael Wonder on 08 Oct 2023
FDA approves Novartis Cosentyx as first intravenous formulation interleukin-17A antagonist for rheumatic diseases
6 October 2023 - First new intravenous treatment option in six years for adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic ...
Posted 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. ...