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RSS FeedPosted by Michael Wonder on 11 Jun 2025
Azurity Pharmaceuticals announces the FDA approval of Xifyrm (meloxicam injection) for the management of moderate to severe pain in adults
10 June 2025 - Azurity Pharmaceuticals today announced that the US FDA has approved Xifyrm (meloxicam injection), an intravenous non-steroidal ...
Posted by Michael Wonder on 10 Jun 2025
Axsome Therapeutics provides update on the new drug application for AXS-14 for the management of fibromyalgia
9 June 2025 - Axsome Therapeutics today announced it has received a refusal to file letter from the US FDA ...
Posted by Michael Wonder on 10 Jun 2025
Alnylam receives European Commission approval for Amvuttra (vutrisiran) for the treatment of ATTR amyloidosis with cardiomyopathy
9 June 2025 - Decision follows recent authorisations in the US and Brazil. ...
Posted by Michael Wonder on 10 Jun 2025
US FDA approves Merck’s Enflonsia (clesrovimab-cfor) for prevention of respiratory syncytial virus lower respiratory tract disease in infants born during or entering their first RSV season
9 June 2025 - Enflonsia is the first and only RSV preventive option administered to infants using the same dose ...
Posted by Michael Wonder on 09 Jun 2025
George Medicines announces FDA approval of Widaplik (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment
9 June 2025 - Commercialisation planning underway with US launch anticipated Q4, 2025. ...
Posted by Michael Wonder on 09 Jun 2025
SMC - June 2025 decisions
9 June 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 07 Jun 2025
European Commission approves Duvyzat for the treatment of Duchenne muscular dystrophy
6 June 2025 - The approval is based on Phase 3 EPIDYS trial data that demonstrated meaningful treatment benefits in ambulant ...
Posted by Michael Wonder on 06 Jun 2025
Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the first-line setting
6 June 2025 - AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for ...
Posted by Michael Wonder on 06 Jun 2025
Merz Aesthetics receives approval from Health Canada for Radiesse as an aesthetic injectable for the treatment of moderate wrinkles in the décolleté area
5 June 2025 - Merz Aesthetics Canada announced today the Health Canada approval for Radiesse for the treatment of moderate ...
Posted by Michael Wonder on 06 Jun 2025
Biogen disappointed by INESSS recommendation on Skyclarys and its impact on Quebec patients with Friedreich ataxia
5 June 2025 - Biogen Canada is disappointed by INESSS's recommendation against listing Skyclarys (omaveloxolone), despite its therapeutic potential for ...
Posted by Michael Wonder on 06 Jun 2025
Sydnexis announces European Commission approval of SYD-101, the first and only pharmaceutical treatment for slowing the progression of paediatric myopia
5 June 2025 - Exclusive licensing partner Santen will commercialise SYD-101 under the brand name Ryjunea in the EU. ...
Posted by Michael Wonder on 05 Jun 2025
TGA approves weight loss drug to treat sleep disorder
4 June 2025 - The country’s medicines regulator has approved the use of a GLP-1 weight-loss drug to treat people ...
Posted by Michael Wonder on 05 Jun 2025
Roche’s Evrysdi tablet approved by European Commission as first and only for spinal muscular atrophy
4 June 2025 - Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with ...
Posted by Michael Wonder on 04 Jun 2025
MHRA approves aumolertinib to treat non-small cell lung cancer
3 June 2025 - The MHRA has approved aumolertinib (Aumseqa) for adult patients with non-small cell lung cancer. ...
Posted by Michael Wonder on 03 Jun 2025
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with newly diagnosed stage IIb/III/IV Hodgkin lymphoma in combination with ECADD
3 June 2025 - Approval based on positive results from the Phase 3 HD21 trial for stage IIb with risk factors/III/IV ...