Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 04 May 2022
Novartis Kymriah receives EC approval as first CAR-T cell therapy for adults with relapsed or refractory follicular lymphoma
4 May 2022 - Approval for relapsed or refractory follicular lymphoma is the third indication for Kymriah in the EU ...
Posted by Michael Wonder on 04 May 2022
Aptose receives fast track designation for HM43239 in relapsed/refractory AML patients and FLT3 mutation
4 May 2022 - Aptose Biosciences today announced that the U.S. FDA has granted fast track designation to HM43239, an oral, ...
Posted by Michael Wonder on 04 May 2022
Phathom Pharmaceuticals announces FDA approval of Voquenza Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquenza Dual Pak (vonoprazan, amoxicillin) for the treatment of H. pylori infection in adults
3 May 2022 - U.S. commercial launch anticipated in the third quarter of 2022. ...
Posted by Michael Wonder on 04 May 2022
X-Therma receives FDA breakthrough device designation for XT-ViVo preservation solution and TimeSeal organ transport device
3 May 2022 - X-Therma announced today that the Center for Devices and Radiological Health of the FDA has granted ...
Posted by Michael Wonder on 04 May 2022
Mirvie receives FDA breakthrough device designation for first test designed to indicate risk of preeclampsia months before symptoms occur
3 May 2022 - Breakthrough has the potential to address a leading cause of maternal mortality that impacts millions of ...
Posted 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
European Commission approves Cabometyx as a second-line treatment for people living with radioactive iodine-refractory differentiated thyroid cancer
3 May 2022 - Approval based on data from the COSMIC-311 Phase 3 trial, in which Cabometyx (cabozantinib) demonstrated a 78% ...
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
First million dollar medicine listed on the PBS
4 May 2022 - Zolgensma has the great honour of being the first medicine listed on the PBS with a ...
Posted by Michael Wonder on 03 May 2022
Boehringer Ingelheim Canada announces reimbursement for Ofev (nintedanib) in seven public drug plans for the treatment of progressive fibrosing interstitial lung diseases
3 May 2022 - Boehringer Ingelheim is pleased to announce that Ofev (nintedanib), is now available for public reimbursement in Quebec, ...
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 ...