Blog
RSS FeedPosted by Michael Wonder on 07 May 2024
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
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 ...
Posted by Michael Wonder on 30 Apr 2024
New Zealand Pharmaceutical Schedule - 1 May 2024
1 May 2024 - The May 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 30 Apr 2024
Schedule of Pharmaceutical Benefits - 1 May 2024
1 May 2024 - The May 2024 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 30 Apr 2024
Dermavant announces FDA acceptance of supplemental new drug application for Vtama (tapinarof) 1% cream for the treatment of atopic dermatitis in adults and children 2 years of age and older
29 April 2024 - FDA PDUFA action expected in Q4, 2024. ...
Posted by Michael Wonder on 30 Apr 2024
Gefapixant for the treatment of patients with refractory or unexplained chronic cough
30 April 2024 - NICE is unable to make a recommendation on the use of gefapixant (Lyfnua) for the treatment of ...
Posted by Michael Wonder on 30 Apr 2024
Oh, Canada: US patients don't want your health policies
29 April 2024 - There's never been a worse time to get sick in Canada. Our northern neighbors must wait ...
Posted by Michael Wonder on 30 Apr 2024
Johnson & Johnson receives positive CHMP opinion recommending full approval for Sirturo (bedaquiline) for treatment of multidrug-resistant tuberculosis
29 April 2024 - Recommendation supported by results from the Phase 3 STREAM Stage 2 study, which show bedaquiline-containing regimens offer ...
Posted by Michael Wonder on 29 Apr 2024
Soleno Therapeutics receives breakthrough therapy designation from US FDA for diazoxide choline extended release tablets in Prader-Willi syndrome
29 April 2024 - Designation is based on data from the Phase 3 program for diazoxide choline. ...