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RSS FeedPosted by Michael Wonder on 11 Apr 2022
Hugel says FDA’s complete response letter will not affect Letybo approval
11 April 2022 - Hugel said a complete response letter from the U.S. FDA on botulinum toxin Letybo requires supplementary ...
Posted by Michael Wonder on 04 Apr 2022
Alnylam announces three month extension of review period for new drug application for vutrisiran
4 April 2022 - New PDUFA goal date scheduled for 14 July 2022. ...
Posted by Michael Wonder on 04 Apr 2022
U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults
4 April 2022 - If approved, Actemra/RoActemra would be the first U.S. FDA approved immunomodulator for the treatment of COVID-19 in ...
Posted by Michael Wonder on 02 Apr 2022
Y-mAbs announces submission of omburtamab biologics license application to FDA
1 April 2022 - Y-mAbs Therapeutics today announced that on 31 March 2022, the company completed the resubmission of its biologics ...
Posted by Michael Wonder on 01 Apr 2022
Merck provides update on FDA review of supplemental biologics license application for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 April 2022 - - Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug ...
Posted by Michael Wonder on 01 Apr 2022
Reata Pharmaceuticals completes rolling submission of new drug application for omaveloxolone for the treatment of patients with Friedreich’s ataxia
31 March 2022 - If approved, omaveloxolone would become the first therapy indicated for the treatment of patients with Friedreich’s ...
Posted by Michael Wonder on 31 Mar 2022
Outlook Therapeutics submits biologics license application to the U.S. Food and Drug Administration for ONS-5010 as a treatment for wet AMD
31 March 2022 - ONS-5010 / LYTENAVA (bevacizumab-vikg), if approved, expected to receive 12 years of marketing exclusivity. ...
Posted by Michael Wonder on 31 Mar 2022
New drug application resubmission
31 March 2022 - NDA submission for Polarean’s hyperpolarised 129Xenon gas drug device combination product ...
Posted by Michael Wonder on 30 Mar 2022
U.S. FDA accepts for priority review Taiho Oncology's new drug application for futibatinib for cholangiocarcinoma
30 March 2022 - Taiho Oncology and Taiho Pharmaceutical announced today that the U.S. FDA has accepted for priority review the ...
Posted by Michael Wonder on 30 Mar 2022
ImmunoGen submits biologics license application to the US Food and Drug Administration for mirvetuximab soravtansine in ovarian cancer
29 March 2022 - Submission based on positive results from pivotal Phase 3 SORAYA trial. ...
Posted by Michael Wonder on 29 Mar 2022
Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA
29 March 2022 - Priority review granted by U.S. FDA. ...
Posted by Michael Wonder on 29 Mar 2022
Santhera and ReveraGen start rolling NDA submission to the FDA for vamorolone for the treatment of Duchenne muscular dystrophy
29 March 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce the initiation of a rolling new drug application submission to the ...
Posted by Michael Wonder on 25 Mar 2022
Bristol Myers Squibb announces new Prescription Drug User Fee Act goal date for Reblozyl (luspatercept-aamt) supplemental biologics license application
25 March 2022 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the supplemental ...
Posted by Michael Wonder on 24 Mar 2022
Fennec Pharmaceuticals resubmits new drug application to the U.S. FDA for Pedmark
24 March 2022 - Fennec Pharmaceuticals today announced the resubmission of its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 23 Mar 2022
Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age
23 March 2022 - Moderna today announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 ...