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 02 May 2024
Labcorp receives FDA approval for first companion diagnostic for use with Pfizer's newly approved gene therapy to treat patients with haemophilia B
29 April 2024 - Labcorp today announced the U.S. FDA has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to ...
Posted by Michael Wonder on 02 May 2024
US FDA approves high concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable biosimilar to Humira
1 May 2024 - Boehringer Ingelheim announced today that the US FDA has approved the high concentration, citrate-free formulation of ...
Posted by Michael Wonder on 02 May 2024
PHARMAC funding will not stretch to new medicines - chief executive
29 April 2024 - A multi-million dollar budget boost for PHARMAC will only keep the lights on, doctors and patient ...
Posted by Michael Wonder on 02 May 2024
CADTH is now Canada’s Drug Agency
1 May 2024 - As of today, we will adopt Canada’s Drug Agency (CDA-AMC) as our new operating name. ...
Posted by Michael Wonder on 02 May 2024
PHARMAC publishes minutes from February 2024 PTAC meeting
1 May 2024 - The outcomes from the February 2024 PTAC meeting are now available. ...
Posted by Michael Wonder on 02 May 2024
Johnson & Johnson submits regulatory applications to EMA for Tremfya (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease
1 May 2024 - Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI ...
Posted by Michael Wonder on 02 May 2024
Neurocrine Biosciences announces US FDA approval of Ingrezza Sprinkle (valbenazine) capsules
30 April 2024 - Neurocrine Biosciences today announced the US FDA has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral ...
Posted by Michael Wonder on 01 May 2024
Iterum Therapeutics resubmits new drug application to US FDA for oral sulopenem
29 April 2024 - Potential approval early Q4, 2024. ...
Posted by Michael Wonder on 01 May 2024
Aquestive Therapeutics receives US FDA approval and market access for Libervant (diazepam) buccal film in paediatric patients ages 2 to 5
29 April 2024 - Announces immediate availability of Libervant 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg for ...
Posted by Michael Wonder on 01 May 2024
Bavarian Nordic initiates rolling submission of biologics license application with FDA for its Chikungunya vaccine candidate
29 April 2024 - Bavarian Nordic today announced that it has initiated the rolling submission process with the US FDA ...
Posted by Michael Wonder on 01 May 2024
Selpercatinib for the treatment of patients with advanced thyroid cancer with RET alterations that has not been treated with systemic therapy
1 May 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 01 May 2024
Pembrolizumab for the treatment of patients 3 years and older with relapsed or refractory classical Hodgkin's lymphoma
1 May 2024 - NICE has published updated evidence-based recommendations on the pembrolizumab (Keytruda) for the treatment of patients with ...
Posted by Michael Wonder on 01 May 2024
Eton Pharmaceuticals announces submission to FDA of new drug application for ET-400 (hydrocortisone oral solution)
30 April 2024 - Company anticipates 10 month review for potential approval in Q1, 2025. ...
Posted by Michael Wonder on 01 May 2024
'What is the price of comfort?': Oncologist raises concerns about newly approved cancer treatment in Canada
30 April 2024 - A new cancer treatment recently approved in Canada promises to cut treatment time down to just ...
Posted by Michael Wonder on 30 Apr 2024
J&J, BMS lose challenges to US drug price negotiation program
29 April 2024 - A US judge on Monday rejected a challenge by Bristol Myers Squibb and Johnson & Johnson ...