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RSS FeedPosted by Michael Wonder on 21 Feb 2026
Vanda Pharmaceuticals announces FDA approval of Bysanti (milsaperidone) for the treatment of bipolar I disorder and schizophrenia - a new chemical entity opening new horizons in psychiatric innovation
20 February 2026 - - Vanda Pharmaceuticals today announced that the US FDA has approved Bysanti (milsaperidone) tablets, a first ...
Posted by Michael Wonder on 21 Feb 2026
MHRA approves zanidatamab (Ziihera) for the treatment of biliary tract cancer
19 February 2026 - Zanidatamab is used when the cancer cannot be removed by surgery and has spread to nearby tissues ...
Posted by Michael Wonder on 21 Feb 2026
FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukaemia or small lymphocytic lymphoma
20 February 2026 - On 19 February 2026, the FDA approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax ...
Posted by Michael Wonder on 20 Feb 2026
Calquence plus venetoclax approved in the US as first all-oral, fixed-duration combination for patients with chronic lymphocytic leukaemia in the 1st-line setting
20 February 2026 - Calquence plus venetoclax demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus chemoimmunotherapy, with 77% ...
Posted by Michael Wonder on 20 Feb 2026
US FDA approves combination treatment of Venclexta (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukaemia
20 February 2026 - AbbVie today announced that the US FDA has approved a supplemental new drug application for the combination ...
Posted 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
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
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
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 18 Feb 2026
NICE recommends first ever disease modifying treatment for ARG1 deficiency
17 February 2026 - NICE has recommended the first disease modifying treatment for arginase 1 deficiency (ARG1-D), an ultra-rare, inherited and ...
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 ...