Blog
RSS FeedPosted by Michael Wonder on 18 Jun 2025
Cancer inhibitors scrapped from basic insurance for some users
18 June 2025 - National health care institute Zorginstituut Nederland has scrapped several cancer inhibiting drugs from the basic health ...
Posted by Michael Wonder on 16 Jan 2024
NRx Pharmaceuticals announces FDA qualified infectious disease product and fast track designation of NRX-101 in complicated urinary tract infection and pyelonephritis
16 January 2024 - QIDP designation grants priority review and an additional 5 years of additional product exclusivity. ...
Posted by Michael Wonder on 16 Jan 2024
US FDA approves Takeda’s HyQvia as maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy
16 January 2024 - Approval based on Phase 3 ADVANCE-CIDP 1 study demonstrating a statistically significant difference in relapse rate in ...
Posted by Michael Wonder on 16 Jan 2024
Vertex announces US FDA approval of Casgevy (exagamglogene autotemcel) for the treatment of transfusion-dependent beta thalassaemia
16 January 2024 - Approximately 1,000 patients in the US 12 years of age and older are now eligible for ...
Posted by Michael Wonder on 16 Jan 2024
Human medicines: highlights of 2023
16 January 2024 - In 2023, EMA recommended 77 medicines for marketing authorisation. ...
Posted by Michael Wonder on 15 Jan 2024
SMC - January 2024 decisions
15 January 2024 - The SMC, which advises on newly-licensed medicines for use by NHSScotland, has today published advice on ...
Posted by Michael Wonder on 15 Jan 2024
Sebelipase alfa for the treatment of patients with Wolman disease (final guidance)
10 January 2023 - Sebelipase alfa is recommended as an option for the treatment of patients with Wolman disease only if ...
Posted by Michael Wonder on 15 Jan 2024
Durvalumab with cisplatin and gemcitabine hydrochloride for the treatment of patients with unresectable or advanced biliary tract cancer
10 January 2024 - NICE has published evidence-based recommendations on the use of durvalumab (Imfinzi) in combination with cisplatin and ...
Posted by Michael Wonder on 15 Jan 2024
Santhera receives approval for Agamree (vamorolone) as a treatment for Duchenne muscular dystrophy in the United Kingdom
12 January 2024 - Launches of Agamree in Europe, with Germany taking the lead, are planned to start in Q1, ...
Posted by Michael Wonder on 14 Jan 2024
Drug Farm receives rare paediatric disease designation from the US FDA for DF-003 to treat ROSAH syndrome
13 January 2024 - Drug Farm announced that the US FDA has granted rare paediatric disease designation for the company’s ...
Posted by Michael Wonder on 14 Jan 2024
RemeGen's RC88 obtained FDA fast track designation, heralds new hope for ovarian cancer patients
12 January 2024 - RemeGen announced recently that its independently developed mesothelin targeting antibody drug conjugate RC88 has been granted fast ...
Posted by Michael Wonder on 14 Jan 2024
Shorla Oncology announces FDA filing acceptance of new drug application for novel formulation to treat breast and ovarian cancer
9 January 2024 - Shorla Oncology announced today that the US FDA has accepted for review the company’s new drug application ...
Posted by Michael Wonder on 14 Jan 2024
DoH publishes revised agenda for March 2024 PBAC meeting (version 3)
5 January 2024 - The Department of Health has published a revised agenda (version 3) for the March 2024 PBAC ...
Posted by Michael Wonder on 14 Jan 2024
1.4 million more people at risk of severe COVID-19 to have access to antiviral Paxlovid
11 January 2024 - A further 1.4 million people who have an increased risk for progression to severe COVID-19 will be ...
Posted by Michael Wonder on 14 Jan 2024
FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 stage III-IVA cervical cancer
15 January 2024 - On 12 January 2024, the FDA approved pembrolizumab (Keytruda) with chemoradiotherapy for patients with FIGO 2014 stage ...
Posted by Michael Wonder on 14 Jan 2024
Public summary documents (first time decisions not to recommend and deferrals) – September 2023 PBAC meeting
12 January 2024 - The public summary documents (first time decisions not to recommend and deferrals) from the September 2023 PBAC ...