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RSS FeedPosted 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
ICER to assess treatment for Parkinson’s disease
9 March 2026 - Report will be subject of CTAF meeting in October 2026; draft scoping document open to public ...
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 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 06 Mar 2026
A month in, TrumpRx falls short of president’s grand promises
5 March 2026 - Few drugs, uneven savings mark early days of Trump’s discount medicines website. ...
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
Hemab Therapeutics receives FDA breakthrough therapy designation for sutacimig in Glanzmann thrombasthenia
5 March 2026 - Sutacimig has potential to become a first in class prophylactic treatment for Glanzmann thrombasthenia, an inherited serious ...
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 04 Mar 2026
Affinia Therapeutics granted FDA fast track designation for AFTX-201 as a treatment for people living with BAG3-associated dilated cardiomyopathy
4 March 2026 - Affinia Therapeutics today announced that the US FDA has granted fast track designation for AFTX-201, a potential ...
Posted by Michael Wonder on 03 Mar 2026
Johnson & Johnson therapy nipocalimab granted US FDA fast track designation in systemic lupus erythematosus
3 March 2026 - Johnson & Johnson today announced that nipocalimaba was granted US FDA fast track designation as a potential ...
Posted by Michael Wonder on 03 Mar 2026
ICER publishes special report on treatment for ulcerative colitis and Crohn’s disease as part of CMS public comment process on Medicare drug price negotiations
3 March 2026 - The ICER today posted a special report on Entyvio (vedolizumab, Takeda) for the treatment of ulcerative ...
Posted by Michael Wonder on 02 Mar 2026
Takeda and Protagonist announce US FDA accepts new drug application and grants priority review for rusfertide as a potential first in class therapy for polycythemia vera
2 March 2026 - Takeda and Protagonist Therapeutics today announced that the US FDA accepted the new drug application and granted ...