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RSS FeedPosted by Michael Wonder on 09 May 2026
argenx announces US FDA approval expanding Vyvgart and Vyvgart Hytrulo for use in all adult patients living with gMG
8 May 2026 - argenx today announced the US FDA approved a label expansion for Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo ...
Posted by Michael Wonder on 09 May 2026
Update from the PBAC (April 2026)
7 May 2026 - The PBAC has published its April 2026 update. ...
Posted by Michael Wonder on 08 May 2026
Update to agenda for the July 2026 PBAC meeting (8 May 2026)
8 May 2026 - The agenda for the July 2026 PBAC meeting has now been updated. ...
Posted by Michael Wonder on 08 May 2026
AZ's Imfinzi wins reimbursement for first-line BTC, HCC treatment in Korea
3 March 2026 - AstraZeneca Korea said Tuesday that Imfinzi (durvalumab) is now covered by national health insurance as of ...
Posted by Michael Wonder on 08 May 2026
NICE approves Duchenne muscular dystrophy treatment givinostat after commercial deal sealed
8 May 2026 - Around 530 people in England will benefit from access to the Duchenne muscular dystrophy treatment givinostat, following ...
Posted by Michael Wonder on 08 May 2026
MHRA approves donidalorsen (Dawnzera) for the treatment of hereditary angioedema
7 May 2026 - The MHRA has today approved donidalorsen (Dawnzera) for use in patients 12 years and older with hereditary angioedema to ...
Posted by Michael Wonder on 08 May 2026
Nuvation Bio announces FDA acceptance of supplemental new drug application for Ibtrozi (taletrectinib) with updated duration of response in advanced ROS1 positive non-small-cell lung cancer
6 May 2026 - Application includes updated TRUST-I TKI naïve median duration of response and median progression-free survival of more than ...
Posted by Michael Wonder on 08 May 2026
FDA grants seventh approval under the National Priority Voucher Pilot Program
8 May 2026 - The US FDA today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion ...
Posted by Michael Wonder on 08 May 2026
Bristol Myers Squibb receives European Commission approval of Sotyktu (deucravacitinib) for the treatment of active psoriatic arthritis in adults
8 May 2026 - Bristol Myers Squibb today announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone ...
Posted by Michael Wonder on 08 May 2026
Update on FDA priority review of Leqembi Iqlik (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer’s disease
8 May 2026 - Eisai and Biogen today announced that the US FDA has extended the review period by three months ...
Posted by Michael Wonder on 08 May 2026
Rznomics announces US FDA regenerative medicine advanced therapy designation granted to RZ-001 for hepatocellular carcinoma
8 May 2026 - RMAT designation based on promising Phase 1b/2a clinical data, including safety profile and preliminary response rates, ...
Posted by Michael Wonder on 07 May 2026
Armata Pharmaceuticals secures FDA fast track designation for AP-SA02
7 May 2026 - Armata Pharmaceuticals today announced that the US FDA has granted fast track designation to AP-SA02, the Company's ...
Posted by Michael Wonder on 07 May 2026
Partner Therapeutics announces receipt of FDA Commissioner's National Priority Voucher for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma
6 May 2026 - Partner Therapeutics today announced that the US FDA has awarded a Commissioner's National Priority Voucher pilot program ...
Posted by Michael Wonder on 07 May 2026
Diakonos Oncology awarded fast track designation by FDA for DOC1021 (dubodencel) in unresectable or metastatic cutaneous melanoma
6 May 2026 - Diakonos Oncology announced today that the US FDA has granted fast track designation to DOC1021, the ...
Posted by Michael Wonder on 06 May 2026
ICER publishes protocol for annual launch price and access report
4 May 2026 - The ICER posted a protocol today outlining how it will conduct its second annual analysis titled the ...