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RSS FeedPosted by Michael Wonder on 19 Feb 2026
ImmunityBio receives authorisation from the European Commission for Anktiva with BCG for non-muscle invasive bladder cancer carcinoma in situ, expanding global access to 33 countries
18 February 2026 - ImmunityBio today announced that the European Commission has granted conditional marketing authorisation for Anktiva (nogapendekin alfa inbakicept) ...
Posted by Michael Wonder on 18 Feb 2026
Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) receives US FDA breakthrough therapy designation for patients with advanced head and neck cancer
18 February 2026 - Johnson & Johnson today announced that the US FDA has granted breakthrough therapy designation for subcutaneous amivantamab ...
Posted by Michael Wonder on 18 Feb 2026
Moderna announces the US FDA will initiate the review of its investigational seasonal influenza vaccine submission
18 February 2026 - Moderna has received a PDUFA goal date of 5 August 2026. ...
Posted by Michael Wonder on 18 Feb 2026
Moderna receives European Commission marketing authorisation for COVID-19 vaccine mNEXSPIKE
17 February 2026 - mNEXSPIKE is the third Moderna vaccine authorised in the European Union, strengthening the Company's respiratory vaccine ...
Posted by Michael Wonder on 18 Feb 2026
Harmony Biosciences receives US FDA approval for Wakix (pitolisant) for the treatment of cataplexy in paediatric narcolepsy
17 February 2026 - Harmony Biosciences today announced that the US FDA has approved its supplemental new drug application for Wakix ...
Posted by Michael Wonder on 18 Feb 2026
Sandoz receives US FDA approval to expand Enzeevu (aflibercept-abzv) label for multiple retinal indications
18 February 2026 - Sandoz today announced that the US FDA has approved an expanded label for Enzeevu (aflibercept-abzv), to include ...
Posted by Michael Wonder on 18 Feb 2026
Deciphera Pharmaceuticals announces US FDA acceptance for filing of new drug application for tirabrutinib in patients with relapsed or refractory PCNSL
17 February 2026 - Deciphera Pharmaceuticals today announced that the US FDA has accepted for filing the new drug application under ...
Posted by Michael Wonder on 18 Feb 2026
Health Canada approves Keytruda SC, a subcutaneous formulation of pembrolizumab across multiple cancer indications
17 February 2026 - Merck announced today that Health Canada has approved Keytruda SC (pembrolizumab injection), a new subcutaneous formulation of ...
Posted by Michael Wonder on 18 Feb 2026
Telix submits European marketing authorisation application for TLX101-Px for brain cancer imaging
18 February 2026 - Telix today announces that it has submitted a marketing authorisation application in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, ...
Posted by Michael Wonder on 18 Feb 2026
Cytokinetics announces European Commission approval of Myqorzo (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy
17 February 2026 - European Commission Approval Based on Results of SEQUOIA-HCM. ...
Posted by Michael Wonder on 17 Feb 2026
Acrotech Biopharma announces FDA approval of Adquey (difamilast 1%) ointment for the treatment of mild to moderate atopic dermatitis
13 February 2026 - Acrotech Biopharma, in collaboration with Otsuka, today announces that the US FDA has approved the new ...
Posted by Michael Wonder on 17 Feb 2026
Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps
17 February 2026 - Approval based on four Phase 3 trials with statistically significant and clinically meaningful primary data across severe ...
Posted by Michael Wonder on 17 Feb 2026
FDA approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
17 February 2026 - Johnson & Johnson today announced the US FDA has approved a new, simplified monthly dosing schedule for ...
Posted by Michael Wonder on 17 Feb 2026
The European Commission approves more effective dose of injectable Wegovy for adults with obesity; clinical study showed people lost about 21% of their body weight on average
17 February 2026 - The European Commission has approved a new 7.2 mg once weekly maintenance dose of Wegovy (semaglutide injection) ...
Posted by Michael Wonder on 17 Feb 2026
US FDA accepts Bristol Myers Squibb's new drug application for iberdomide in patients with relapsed or refractory multiple myeloma
17 February 2026 - Bristol Myers Squibb today announced that the US FDA has accepted a new drug application for ...