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RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 Feb 2026
neffy, adrenaline nasal spray, now approved to treat anaphylaxis in Australia
16 February 2026 - CSL Seqirus has today announced that neffy adrenaline (epinephrine) nasal spray is now available and has been ...
Posted by Michael Wonder on 14 Feb 2026
STADA and Bio-Thera receive European marketing authorization for Gotenfia, a biosimilar to Simponi
13 February 2026 - STADA and Bio-Thera Solutions have received a marketing authorisation from the European Commission for their Gotenfia ...
Posted by Michael Wonder on 13 Feb 2026
Disc Medicine receives complete response letter from FDA for bitopertin for the treatment of EPP
13 February 2026 - Disc Medicine announced that the US FDA today issued a complete response letter for the new drug ...
Posted by Michael Wonder on 13 Feb 2026
European Commission approves Amgen's Uplinza for generalised myasthenia gravis
12 February 2026 - Amgen today announced the European Commission has approved Uplinza (inebilizumab) as an add-on treatment to standard therapy ...
Posted by Michael Wonder on 13 Feb 2026
PTC Therapeutics provides regulatory update on Translarna
12 February 2026 - PTC Therapeutics announced today that it has withdrawn the new drug application resubmission for Translarna (ataluren) ...
Posted by Michael Wonder on 13 Feb 2026
Agilent receives FDA approval for PD-L1 IHC 22C3 pharmDx in epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
11 February 2026 - Approval expands PD-L1 testing to support treatment decisions with Keytruda (pembrolizumab). ...