Blog
RSS FeedPosted by Michael Wonder on 04 May 2022
SeaStar Medical granted FDA breakthrough device designation for a novel immunomodulatory therapy for acute kidney injury patients
3 May 2022 - Designation helps enable accelerated regulatory review of up-coming pivotal clinical trial for treatment in adult patients with ...
Posted by Michael Wonder on 04 May 2022
Imfinzi plus chemotherapy granted priority review in the US for patients with locally advanced or metastatic biliary tract cancer based on TOPAZ-1 Phase III trial
4 May 2022 - First Phase 3 trial in this setting to show improved overall survival with an immunotherapy added ...
Posted by Michael Wonder on 04 May 2022
Pliant Therapeutics receives FDA fast track designation for PLN-74809 for the treatment of idiopathic pulmonary fibrosis
3 May 2022 - Pliant Therapeutics announced today that PLN-74809, its oral, dual-selective αvß6/αvß1 integrin inhibitor, has received fast track ...
Posted by Michael Wonder on 04 May 2022
Graphite Bio announces U.S. FDA fast track designation granted to GPH101 for the treatment of sickle cell disease
3 May 2022 - GPH101 is an investigational next-generation gene-edited therapy designed to potentially provide a one time cure for ...
Posted by Michael Wonder on 03 May 2022
U.S. FDA accepts supplemental new drug application and grants priority review for darolutamide in combination with docetaxel for metastatic hormone-sensitive prostate cancer
3 May 2022 - Application is being reviewed concurrently among participating international health authorities under the FDA Oncology Center of ...
Posted by Michael Wonder on 03 May 2022
Belite Bio receives FDA fast track designation for LBS-008
3 May 2022 - LBS-008 (aka tinlarebant) is the Company’s orally administered tablet for the treatment of Stargardt disease. ...
Posted by Michael Wonder on 03 May 2022
Unwanted advice? Frequency, characteristics and outcomes of negative advisory committee votes for FDA approved drugs
2 May 2022 - Substantial controversy arose in 2021 when the FDA approved the Alzheimer’s disease drug aducanumab (Aduhelm) under its ...
Posted by Michael Wonder on 03 May 2022
HutchMed receives complete response letter from the U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
2 May 2022 - HutchMed announced that the U.S. FDA has issued a complete response letter regarding the new drug application ...
Posted by Michael Wonder on 03 May 2022
Limaca Medical receives FDA breakthrough device designation
2 May 2022 - Limaca's precision GI endoscopic biopsy device advances precision medicine. ...
Posted by Michael Wonder on 02 May 2022
Vaxxinity receives FDA fast track designation for UB-311 for treatment of Alzheimer’s disease
2 May 2022 - Vaxxinity today announced that UB-311, an anti-amyloid beta immunotherapeutic vaccine, has been granted fast track designation by ...
Posted by Michael Wonder on 02 May 2022
SpineX receives FDA breakthrough device designation for SCiP
2 May 2022 - SpineX’s proprietary non-surgical device SCiP offers new hope for children with cerebral palsy. ...
Posted by Michael Wonder on 02 May 2022
Orphalan announces FDA approval of Cuvrior for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine
2 May 2022 - Orphalan announces FDA approval of Cuvrior for the treatment of adult patients with stable Wilson’s disease ...
Posted by Michael Wonder on 02 May 2022
Sage Therapeutics and Biogen initiate rolling submission of new drug application to US FDA for zuranolone for the potential treatment of major depressive disorder
2 May 2022 - The companies expect to complete submission of the new drug application for treatment of major depressive ...
Posted by Michael Wonder on 02 May 2022
Junshi Biosciences and Coherus receive complete response letter from U.S. FDA for toripalimab BLA
2 May 2022 - The complete response letter requests a quality process change Junshi Biosciences and Coherus believe is readily addressable. ...
Posted by Michael Wonder on 02 May 2022
Axsome Therapeutics receives FDA complete response letter for new drug application for AXS-07 for the acute treatment of migraine
2 May 2022 - No clinical efficacy or safety issues raised and no additional clinical studies required by FDA to support ...