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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 07 Feb 2026
Pendopharm announces the approval of Yorvipath (palopegteriparatide injection) for the treatment of chronic hypoparathyroidism in adults
6 February 2026 - Pendopharm announced today that Health Canada has granted market authorisation for Yorvipath (palopegteriparatide injection), a parathyroid ...
Posted by Michael Wonder on 07 Feb 2026
Kisqali receives positive draft recommendation from Canada's Drug Agency for all eligible early breast cancer patients at high risk of recurrence
6 February 2026 - The draft recommendation for Kisqali (ribociclib tablets) from Canada's Drug Agency (CDA-AMC) supports public reimbursement for hormone ...
Posted by Michael Wonder on 07 Feb 2026
Incyte announces positive CHMP opinion for Zynyz (retifanlimab) for first-line treatment of advanced squamous cell carcinoma of the anal canal
30 January 2026 - The CHMP positive opinion is based on data from the Phase 3 POD1UM-303/InterAACT2 trial which showed patients ...
Posted by Michael Wonder on 06 Feb 2026
White House debuts drug buying site TrumpRx, with roughly 40 medications
5 February 2026 - Obesity and infertility treatments are among the first crop to appear with discounts on the government-run platform. ...
Posted by Michael Wonder on 06 Feb 2026
FDA grants priority review for Hympavzi (marstacimab) sBLA for the treatment of two haemophilia A or B patient populations with significant medical need
6 February 2026 - Pfizer today announced that the US FDA has accepted and granted priority review for the company’s ...
Posted by Michael Wonder on 06 Feb 2026
Nucala (mepolizumab) approved by the European Commission for the treatment of chronic obstructive pulmonary disease
6 February 2026 - GSK today announced the European Commission has approved Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 , ...
Posted by Michael Wonder on 06 Feb 2026
Teva Canada announces approval of expanded indication of Ajovy (fremanezumab solution for subcutaneous injection), the first anti-CGRP preventive treatment for paediatric episodic migraine
4 February 2026 - Teva Canada announced today that Health Canada has approved an expanded indication for Ajovy (fremanezumab solution for ...
Posted by Michael Wonder on 06 Feb 2026
Merck announces Health Canada approval of Enflonsia for the prevention of RSV in newborns and infants
5 February 2026 - Approval is based on the CLEVER and SMART clinical trial results. ...
Posted by Michael Wonder on 06 Feb 2026
IBSA USA announces FDA approval of Vybrique, the first and only oral film to treat men with erectile dysfunction
5 February 2026 - US commercial availability anticipated in March 2026. ...
Posted by Michael Wonder on 05 Feb 2026
PHARMAC proposes wider access to a treatment for people with a rare blood cancer
4 February 2026 - People in New Zealand living with a rare type of blood cancer, systemic anaplastic large cell ...
Posted by Michael Wonder on 05 Feb 2026
Oncolytics Biotech receives FDA fast track designation for pelareorep in second-line KRAS mutant MSS metastatic colorectal cancer
4 February 2026 - Pelareorep now has fast track designation for two gastro-intestinal cancers, solidifying its potential as an immunotherapeutic ...
Posted by Michael Wonder on 05 Feb 2026
Leads Biolabs' GPRC5D/CD3 bispecific T-cell engager LBL-034 earns FDA fast track designation—accelerating launch of potential best in class therapy for relapsed/refractory multiple myeloma
27 January 2026 - Nanjing Leads Biolabs today announced that its key investigational asset LBL-034, a GPRC5D/CD3 bi-specific antibody with a ...
Posted by Michael Wonder on 04 Feb 2026
Cumberland Pharmaceuticals receives FDA fast track designation for its ifetroban Duchenne muscular dystrophy program
4 February 2026 - Cumberland Pharmaceuticals announced today that the US FDA has granted fast track designation for its novel oral ...
Posted by Michael Wonder on 04 Feb 2026
EURneffy 1 mg (adrenaline nasal spray) recommended for approval in the EU for emergency treatment of type 1 allergic reactions, including anaphylaxis in children weighing ≥15 kg to <30 kg
2 February 2026 - ARS Pharma’s partner, ALK-Abelló A/S, who owns the rights to market EURneffy in the EU, will distribute ...
Posted by Michael Wonder on 04 Feb 2026
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in adults and adolescents with vitiligo
3 February 2026 - Submissions are supported by data from the Phase 3 Viti-Up clinical studies demonstrating upadacitinib achieved the co-primary ...