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RSS FeedPosted 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 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
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). ...
Posted by Michael Wonder on 12 Feb 2026
FDA refusing to review Moderna mRNA flu shot application
11 February 2026 - Moderna said on Tuesday that the FDA has refused to review its application for an mRNA flu ...
Posted by Michael Wonder on 12 Feb 2026
Price, therapeutic value impact international submission times for new drugs
11 February 2026 - The US tends to receive regulatory submissions earlier and more often than other major international regulators, ...
Posted by Michael Wonder on 12 Feb 2026
BioMarin receives Health Canada Notice of Compliance with conditions for Voxzogo for achondroplasia
11 February 2026 - BioMarin has today announced Health Canada has granted a Notice of Compliance with Conditions for Voxzogo ...
Posted by Michael Wonder on 11 Feb 2026
Moderna receives refusal to file letter from the US FDA for its investigational seasonal influenza vaccine, mRNA-1010
10 February 2026 - Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...
Posted by Michael Wonder on 10 Feb 2026
FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
10 February 2026 - Today, the FDA approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, ...
Posted by Michael Wonder on 10 Feb 2026
RegenxBio announces regulatory update on RGX-121 BLA for MPS II
9 February 2026 - RegenXBio today announced that the US FDA has issued a complete response letter regarding its biologics ...
Posted by Michael Wonder on 09 Feb 2026
SMC - February 2026 decisions
9 February 2026 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 09 Feb 2026
ICER releases evidence report on therapies for IgA nephropathy
9 February 2026 - All three therapies exhibit net health benefits, but uncertainties remain around the magnitude of long-term improvements ...
Posted by Michael Wonder on 08 Feb 2026
FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma
6 February 2026 - FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma. ...