Blog
RSS FeedPosted by Michael Wonder on 14 Jun 2025
NICE leads the way in approving breakthrough treatment for multiple myeloma
13 June 2025 - People in England will become the first in the world to receive belantamab mafodotin for this indication ...
Posted by Michael Wonder on 13 Jun 2025
AbbVie’s Epkinly, Eisai’s Lenvima pass reimbursement review; Janssen’s Tecvayli fails
11 June 2025 - AbbVie Korea's Epkinly (epcoritamab), a treatment for adults with relapsed or refractory diffuse large B-cell lymphoma ...
Posted by Michael Wonder on 13 Jun 2025
UCB's new psoriasis biologic Bimzelx debuts in Korea with reimbursement
13 June 2025 - Belgium-based UCB's novel psoriasis therapy, Bimzelx (bimekizumab), has officially entered Korea's competitive plaque psoriasis market with ...
Posted by Michael Wonder on 13 Jun 2025
FDA grants priority review for zoliflodacin new drug application for the treatment of uncomplicated gonorrhoea
12 June 2025 - Innoviva Specialty Therapeutics today announced that the US FDA has granted priority review for the new drug ...
Posted by Michael Wonder on 12 Jun 2025
Sumitomo Pharma America announces that nuvisertib (TP-3654) has received FDA fast track designation for the treatment of myelofibrosis
12 June 2025 - Nuvisertib (TP-3654), an investigational highly selective oral PIM1 kinase inhibitor, is being evaluated in patients with ...
Posted by Michael Wonder on 12 Jun 2025
FDA approves neo-adjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
12 June 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck ...
Posted by Michael Wonder on 12 Jun 2025
FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
12 June 2025 - Today, the FDA approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade ...
Posted by Michael Wonder on 12 Jun 2025
EMA 2024 annual report is published
10 June 2025 - The EMA’s annual report 2024 published today gives insights into the Agency’s strategic priorities and contributions ...
Posted by Michael Wonder on 12 Jun 2025
US FDA approves tablet formulation of BeOne’s Brukinsa for all approved indications
11 June 2025 - New formulation provides patients with a simplified dosing experience—reducing pill burden and enhancing ease of administration—while ...
Posted by Michael Wonder on 12 Jun 2025
Gilead’s Trodelvy wins Korean coverage for breast cancer -- too late for some and still off-limits up front
12 June 2025 - It took two years, 100,000 signatures, and a wave of public pressure from patients and doctors. ...
Posted by Michael Wonder on 12 Jun 2025
Health Canada authorises PiaSky (crovalimab for injection) as the first monthly (every four weeks) subcutaneous treatment for people with paroxysmal nocturnal haemoglobinuria
11 June 2025 - Roche Canada is pleased to announce that Health Canada has authorised PiaSky (crovalimab for injection) as ...
Posted by Michael Wonder on 11 Jun 2025
Cantargia’s nadunolimab antibody awarded US FDA fast track designation
11 June 2025 - Cantargia today announced that the US FDA has granted fast track designation to nadunolimab, Cantargia's anti-IL1RAP antibody ...
Posted by Michael Wonder on 11 Jun 2025
FDA approves taletrectinib for ROS1 positive non-small cell lung cancer
11 June 2025 - Today, the FDA approved taletrectinib (Ibtrozi, Nuvation Bio), a kinase inhibitor, for adults with locally advanced ...
Posted by Michael Wonder on 11 Jun 2025
US FDA approves expanded indication for AbbVie's Mavyret (glecaprevir/pibrentasvir) as first and only treatment for people with acute hepatitis C virus
11 June 2025 - AbbVie today announced that the US FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral ...
Posted by Michael Wonder on 11 Jun 2025
Priorities for a new FDA
10 June 2025 - Why does it take more than 10 years for a new drug to come to market? Why ...