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 14 May 2021
BridgeBio Pharma receives FDA fast track designation for investigational gene therapy for congenital adrenal hyperplasia
14 May 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation to BBP-631, an investigational adeno-associated ...
Posted by Michael Wonder on 14 May 2021
PharmaEssentia resubmits application to the U.S. FDA for ropeginterferon alfa-2b-njft to treat polycythemia vera
14 May 2021 - PharmaEssentia today announced the resubmission of its biologics license application to the U.S. FDA, seeking approval for ...
Posted by Michael Wonder on 14 May 2021
Vaccine patent waivers deserve a warning label
13 May 2021 - The move to suspend patents on COVID-19 vaccines opens up a major risk to the way the ...
Posted by Michael Wonder on 14 May 2021
Migraine drug Emgality to be listed on PBS, saving sufferers thousands of dollars
13 May 2021 - People living with migraine will no longer face the financial headache of forking out thousands of ...
Posted by Michael Wonder on 14 May 2021
MSAC publishes agenda for upcoming ESC meeting
14 May 2021 - The MSAC Secretariat has published a list of the applications scheduled to be considered at the ...
Posted by Michael Wonder on 14 May 2021
Molzym announces FDA breakthrough device designation for its molecular diagnostic test system – sepsis, ioint & implant infections, infective endocarditis, bacterial meningitis
10 May 2021 - Molzym’s unique technology for molecular microbial diagnostics was granted breakthrough device designation by the FDA in light ...
Posted by Michael Wonder on 14 May 2021
Japan’s Ministry of Health, Labour and Welfare grants priority review for enfortumab vedotin new drug application
14 May 2021 - New drug application, submitted in March, is for locally advanced or metastatic urothelial cancer that has ...
Posted by Michael Wonder on 13 May 2021
Pfizer warns that IP waiver for COVID-19 vaccines may invite ‘copycat medicines’
13 May 2021 - Company says removing intellectual property protections would make it ‘harder’ to make vaccines in the short term. ...
Posted by Michael Wonder on 13 May 2021
Pilot of new health technology evaluation process for antimicrobials
7 May 2021 - Research to develop novel antibiotics has in recent years been seen as commercially unattractive due to limited ...
Posted by Michael Wonder on 13 May 2021
Long waits for life saving drugs harming Canadians: report
13 May 2021 - Canadians wait 15 months longer on average for new and potentially life-saving medications compared to Americans ...
Posted by Michael Wonder on 13 May 2021
Strongbridge Biopharma announces U.S. FDA filing acceptance of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome
13 May 2021 - FDA Sets Prescription Drug User Fee Act target action date of 1 January 2022. ...
Posted by Michael Wonder on 13 May 2021
Palisade Bio receives FDA fast track designation for LB1148 for reduction of adhesions following abdominal and pelvic surgery
13 May 2021 - LB1148 was previously granted fast track designation from the U.S. FDA for the treatment of post-operative GI ...
Posted by Michael Wonder on 13 May 2021
Heron Therapeutics announces U.S. FDA approval of Zynrelef for the management of post-operative pain for up to 72 hours
13 May 2021 - Full U.S. commercial launch of Zynrelef is planned for July 2021. ...
Posted by Michael Wonder on 13 May 2021
Australia secures Moderna vaccines
13 May 2021 - The Australian Government has secured 25 million doses of the Moderna COVID-19 vaccine to further diversify our ...
Posted by Michael Wonder on 13 May 2021
Eisai Korea to stop supply of blood cancer drug Symbenda this year
13 May 2021 - Symbenda (bendamustine), a treatment for blood cancer, is expected to become unavailable in Korea within this ...