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RSS FeedPosted by Michael Wonder on 17 Mar 2026
Sun Pharma announces US FDA acceptance of supplemental biologics license application for Ilumya (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis
16 March 2026 - Sun Pharmaceutical Industries announced that the US FDA has accepted for review the supplemental biologics license ...
Posted by Michael Wonder on 16 Mar 2026
Cogent Biosciences announces FDA acceptance of new drug application for bezuclastinib in patients with non-advanced systemic mastocytosis
16 March 2026 - NDA based on positive clinical results from the SUMMIT pivotal trial in which bezuclastinib demonstrated clear clinical ...
Posted by Michael Wonder on 16 Mar 2026
Telix resubmits NDA to US FDA for TLX101-Px (Pixclara) brain cancer imaging candidate
16 March 2026 - Telix Pharmaceuticals today announces the resubmission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 13 Mar 2026
Novartis Cosentyx receives FDA approval for paediatric patients aged 12+ with moderate to severe hidradenitis suppurativa
13 March 2026 - Novartis announced today that Cosentyx (secukinumab) received US FDA approval for treating paediatric patients 12 years ...
Posted by Michael Wonder on 13 Mar 2026
GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk
13 March 2026 - GSK today announced that the US FDA has expanded the approved age indication of Arexvy (respiratory syncytial ...
Posted by Michael Wonder on 11 Mar 2026
Lenz Therapeutics announces submission of marketing authorisation application to the EMA for Vizz for the treatment of presbyopia
10 March 2026 - Lenz Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 10 Mar 2026
FDA approves first treatment for patients with cerebral folate transport deficiency
10 March 2026 - The US FDA today approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of ...
Posted by Michael Wonder on 10 Mar 2026
Sangamo Therapeutics advances rolling submission of BLA to US FDA for ST-920 in Fabry disease
9 March 2026 - Sangamo Therapeutics today announced advancement of the rolling submission of a BLA to the FDA seeking ...
Posted by Michael Wonder on 10 Mar 2026
ImmunityBio announces resubmission of supplemental BLA to the FDA for Anktiva plus BCG in BCG unresponsive NMIBC with papillary disease following agency review of additional data
9 March 2026 - ImmunityBio today announced that the US FDA has acknowledged receipt of its supplemental biologics license application ...
Posted by Michael Wonder on 09 Mar 2026
Enhertu granted priority review in the US as post-neoadjuvant treatment for patients with HER2 positive early breast cancer
9 March 2026 - Based on DESTINY-Breast05 Phase 3 trial results, which showed Enhertu reduced the risk of invasive disease ...
Posted by Michael Wonder on 07 Mar 2026
FDA official offers insights on agency’s criteria for real world data in regulatory submissions
6 March 2026 - The US FDA will consider several factors when determining whether to accept real world data and ...
Posted by Michael Wonder on 07 Mar 2026
US FDA approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis
6 March 2026 - Significantly more patients treated with once daily, oral Sotyktu achieved an ACR20 response compared with placebo at ...
Posted by Michael Wonder on 07 Mar 2026
Lantheus announces FDA approval of Pylarify TruVu (piflufolastat F 18) injection
6 March 2026 - Pylarify TruVu is expected to launch in Q4, 2026, with a phased geographic rollout to support a ...
Posted by Michael Wonder on 05 Mar 2026
FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma
5 March 2026 - Today, the FDA approved teclistamab (Tecvayli, Janssen Biotech) in combination with daratumumab hyaluronidase-fihj for adult patients ...
Posted by Michael Wonder on 05 Mar 2026
PDUFA action date for Hansa Biopharma's imlifidase BLA set for 19 December 2026
4 March 2026 - If approved, imlifidase will be the first treatment to address highly sensitised patients awaiting kidney transplantation. ...