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RSS FeedPosted by Michael Wonder on 09 Sep 2021
Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
9 September 2021 - FDA PDUFA target action date is 6 May 2022. ...
Posted by Michael Wonder on 09 Sep 2021
FDA grants Jardiance breakthrough therapy designation for heart failure with preserved ejection fraction
9 September 2021 - Designation is based on results from the EMPEROR-Preserved Phase 3 trial, which established Jardiance as the first ...
Posted by Michael Wonder on 09 Sep 2021
Albireo sells priority review voucher for $105 million
7 September 2021 - PRV was granted to Albireo with the FDA approval of Bylvay (odevixibat) in July. ...
Posted by Michael Wonder on 08 Sep 2021
Intelivation Technologies received FDA approval for the Advantage-C PEEK cervical interbody fusion device
8 September 2021 - Intelivation Technologies announced today that they have achieved FDA 510(k) Clearance of the Advantage-C PEEK cervical ...
Posted by Michael Wonder on 08 Sep 2021
Phathom Pharmaceuticals submits two NDAs to U.S. FDA for vonoprazan-based treatment regimens for the treatment of H. pylori infection
8 September 2021 - Phathom Pharmaceuticals announced today that it has submitted two new drug applications to the U.S. FDA for ...
Posted by Michael Wonder on 08 Sep 2021
FDA grants Madorra breakthrough device designation status for treatment of moderate to severe vulvovaginal atrophy
8 September 2021 - Clinical trials of Madorra therapy system show promising results for treatment of vulvovaginal atrophy. ...
Posted by Michael Wonder on 08 Sep 2021
HiberCell receives fast track designation from FDA for first in human studies of PERK inhibitor (PERKi) HC-5404-FU
8 September 2021 - C-5404-FU PERKi program is currently in a Phase 1a clinical trial for the treatment of solid ...
Posted by Michael Wonder on 07 Sep 2021
U.S. FDA accepts for priority review supplemental new drug application for Oxbryta (voxelotor) for the treatment of sickle cell disease in children ages 4 to 11
7 September 2021 - New drug application for Oxbryta dispersible tablets also accepted for priority review. ...
Posted by Michael Wonder on 06 Sep 2021
Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm
6 September 2021 - Congress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its ...
Posted by Michael Wonder on 05 Sep 2021
America desperately needs a much better FDA
2 September 2021 - In the early 1960s, an unflappable FDA scientist named Frances Kelsey spared the nation from the horrors ...
Posted by Michael Wonder on 03 Sep 2021
Impel NeuroPharma announces U.S. FDA approval of Trudhesa (dihydroergotamine mesylate) nasal spray for the acute treatment of migraine
3 September 2021 - Commercial launch of Trudhesa is planned for early October 2021. ...
Posted by Michael Wonder on 03 Sep 2021
FDA acceptance for filing of new drug application for trientine tetrahydrochloride for the treatment of Wilson’s disease
2 September 2021 - New drug application supported by positive data from Phase 3 CHELATE clinical trial. ...
Posted by Michael Wonder on 02 Sep 2021
Novartis gets FDA fast track designation for LNA043 in knee osteoarthritis
2 September 2021 - Novartis AG on Thursday said the U.S. FDA granted fast track designation to LNA043 for the ...
Posted by Michael Wonder on 02 Sep 2021
House Committees demand FDA records on Alzheimer’s drug approval
2 September 2021 - The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter. ...
Posted by Michael Wonder on 02 Sep 2021
FDA reaches milestone in competitive generic therapy drug approvals
2 September 2021 - This week, the FDA reached the milestone of approving more than 100 generic drug applications with a ...