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 Feb 2023
Verve Therapeutics announces VERVE-101 awarded Innovation Passport by the UK MHRA for the treatment of heterozygous familial hypercholesterolaemia
14 February 2023 - Verve Therapeutics today announced that VERVE-101 has been awarded the Innovation Passport for the treatment of ...
Posted by Michael Wonder on 14 Feb 2023
Who helps keep drug costs affordable? Pharmacy benefit managers.
14 February 2023 - You may have noticed an inordinate number of television commercials offering opinions on the price of prescription ...
Posted by Michael Wonder on 14 Feb 2023
FDA grants 15 June 2023 PDUFA date to Albireo for Bylvay in Alagille syndrome
14 February 2023 - ASSERT study demonstrated efficacy of Bylvay in pruritus, bile acids and sleep with a low drug-related diarrhoea ...
Posted by Michael Wonder on 14 Feb 2023
Mirum Pharmaceuticals submits supplemental new drug application to FDA for Livmarli in patients with cholestatic pruritus in progressive familial intrahepatic cholestasis
14 February 2023 - Submission based on MARCH Phase 3 study with high statistical significance (p<0.0001) between LIVMARLI versus placebo, and ...
Posted by Michael Wonder on 14 Feb 2023
Soligenix receives refusal to file letter from US FDA for HyBryte new drug application in the treatment of cutaneous T-Cell lymphoma
14 February 2023 - Soligenix intends to seek guidance from the FDA on how to further advance HyBryte towards potential ...
Posted by Michael Wonder on 14 Feb 2023
Scotland becomes first part of UK to approve new cervical cancer drug
13 February 2023 - The SMC has approved the use of the drug pembrolizumab – which is also known as ...
Posted by Michael Wonder on 14 Feb 2023
Top FDA official interested in ‘Project Orbis’ for cell and gene therapies
13 February 2023 - A top official from the US FDA said he wants to see something similar to the agency’s ...
Posted by Michael Wonder on 14 Feb 2023
Camurus withdraws variation application for CAM2038 to include chronic pain
13 February 2023 - Camurus announced today that it has notified the EMA of its decision to withdraw the Type ...
Posted by Michael Wonder on 13 Feb 2023
Assessment of FDA approved drugs not recommended for use or reimbursement in other countries (2017-2020)
13 February 2023 - In this cross-sectional study of all 206 new US drug approvals in 2017 through 2020, 47 drugs ...
Posted by Michael Wonder on 13 Feb 2023
US FDA approval of drugs not meeting pivotal trial primary outcomes (2018-2021)
13 February 2023 - In June 2021, the US FDA granted accelerated approval to aducanumab for the treatment of Alzheimer disease ...
Posted by Michael Wonder on 13 Feb 2023
Like Medicare, the PBS urgently needs overhauling – for all our sakes
10 February 2023 - Trent Zimmerman says it would be a mistake for Australia to narrow its health reform agenda ...
Posted by Michael Wonder on 13 Feb 2023
SMC - February 2023 decisions
13 February 2023 - The SMC, which advises on newly-licensed medicines for use by NHSScotland, has today published advice on ...
Posted by Michael Wonder on 13 Feb 2023
Ocuphire announces FDA acceptance of new drug application and PDUFA date of 28 September 2023 for Nyxol eye drops for reversal of mydriasis
13 February 2023 - If approved later this year, Nyxol could be the only commercially available eye drop for reversal of ...
Posted by Michael Wonder on 13 Feb 2023
US FDA issues a CRL for the biologics license application for bevacizumab
12 February 2023 - The US FDA has issued a complete response letter for the biologics license application for bevacizumab ...
Posted by Michael Wonder on 13 Feb 2023
Ironwood Pharmaceuticals announces FDA filing acceptance and priority review of supplemental new drug application for Linzess (linaclotide) for functional constipation in children and adolescents ages 6-17 years old
13 February 2023 - FDA assigns second quarter 2023 target action date. ...