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RSS FeedPosted by Michael Wonder on 21 Feb 2022
Allarity Therapeutics receives refusal to file letters from U.S. FDA
18 February 2022 - Allarity intends to seek guidance from the FDA on how to further advance dovitinib and its ...
Posted by Michael Wonder on 17 Feb 2022
U.S. FDA accepts for priority review Bristol Myers Squibb’s supplemental biologics license application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
17 February 2022 - U.S. FDA has assigned a target action date of 24 June 2022. ...
Posted by Michael Wonder on 16 Feb 2022
Acadia Pharmaceuticals announces resubmission of supplemental new drug application to U.S. FDA for Nuplazid (pimavanserin) to treat Alzheimer’s disease psychosis
16 February 2022 - Acadia Pharmaceuticals announced today that it has resubmitted its supplemental new drug application for pimavanserin for ...
Posted by Michael Wonder on 16 Feb 2022
U.S. FDA accepts Mirati Therapeutics' new drug application for adagrasib as treatment of previously treated KRAS G12C mutated non-small cell lung cancer
15 February 2022 - Mirati Therapeutics today announced that the U.S. FDA accepted the new drug application for adagrasib for ...
Posted by Michael Wonder on 14 Feb 2022
Spectrum Pharmaceuticals announces acceptance of new drug application filing for poziotinib
11 February 2022 - Spectrum Pharmaceuticals today announced that its new drug application for poziotinib has been accepted for review by ...
Posted by Michael Wonder on 12 Feb 2022
Pfizer and BioNTech provide update on rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age
11 February 2022 - Pfizer and BioNTech today announced plans to extend their rolling submission to the U.S. FDA seeking ...
Posted by Michael Wonder on 10 Feb 2022
FDA accepts Dupixent (dupilumab) for priority review in children aged 6 months to 5 years with moderate to severe atopic dermatitis
10 February 2022 - If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled ...
Posted by Michael Wonder on 10 Feb 2022
Gamida Cell initiates rolling submission of biologics license application for omidubicel
9 February 2022 - Gamida Cell today announced that it has initiated the biologics license application rolling submission process with the ...
Posted by Michael Wonder on 06 Feb 2022
Cytokinetics announces FDA acceptance of new drug application for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction
4 February 2022 - PDUFA target action date set for 30 November 2022. ...
Posted by Michael Wonder on 03 Feb 2022
Lipocine announces its partner received FDA acceptance of NDA resubmission for Tlando
3 February 2022 - PDUFA target action date set for 28 March 2022. ...
Posted by Michael Wonder on 02 Feb 2022
Jazz Pharmaceuticals completes U.S. FDA supplemental biologics license application for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Monday/Wednesday/Friday dosing schedule
2 February 2022 - Phase 2/3 trial data, the basis for submission, demonstrates Rylaze maintains a clinically meaningful level of nadir ...
Posted by Michael Wonder on 01 Feb 2022
Pfizer and BioNTech initiate rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age following request from U.S. FDA
1 February 2022 - Companies plan to submit additional data on a third 3 µg dose in this age group in ...
Posted by Michael Wonder on 01 Feb 2022
Reata Pharmaceuticals initiates rolling submission of new drug application with U.S. FDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia
31 January 2022 - Plans to complete submission by the end of the first quarter of 2022. ...
Posted by Michael Wonder on 01 Feb 2022
Novavax submits request to the U.S. FDA for emergency use authorisation of COVID-19 Vaccine
31 January 2022 - NVX-CoV2373 demonstrated overall efficacy of ~90% in PREVENT-19 clinical trial conducted during the emergence of variant ...
Posted by Michael Wonder on 28 Jan 2022
Updates on Olumiant (baricitinib) FDA review for atopic dermatitis
28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...