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RSS FeedPosted 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 12 Mar 2026
ARTHEx Biotech granted FDA fast track designation for ATX-01 for the treatment of myotonic dystrophy type 1
11 March 2026 - ARTHEx Biotech today announced that the US FDA has granted fast track designation to ATX-01 for the ...
Posted by Michael Wonder on 12 Mar 2026
Quoin Pharmaceuticals announces FDA grants fast track designation for QRX003 for the treatment of Netherton syndrome
11 March 2026 - Quoin Pharmaceuticals today announced that the US FDA has granted fast track designation to QRX003 lotion (4%) ...
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
Redx’s RXC008 granted US FDA fast track designation for fibrostenotic Crohn’s disease
10 March 2026 - Redx Pharma announces that the US FDA has granted fast track designation to RXC008, a GI ...
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
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
FDA takes further steps to streamline biosimilar development and make medicines more affordable
9 March 2026 - The US FDA today announced another major step in its initiative to streamline the development of biosimilar ...
Posted by Michael Wonder on 09 Mar 2026
Ipsen voluntarily withdraws Tazverik (tazemetostat) in follicular lymphoma and epithelioid sarcoma
9 March 2026 - Ipsen announced today that it is voluntarily withdrawing Tazverik (tazemetostat) in all indications from all Ipsen ...
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 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. ...
Posted by Michael Wonder on 05 Mar 2026
Priovant announces FDA acceptance and priority review of new drug application for brepocitinib in dermatomyositis
3 March 2026 - Priovant Therapeutics today announced that the US FDA has accepted its new drug application for brepocitinib for ...