Blog
RSS FeedPosted by Michael Wonder on 02 Aug 2025
Update on US regulatory review of supplemental biologics license application
1 August 2025 - The US FDA issued a complete response letter for the supplemental biologics license application for Darzalex ...
Posted by Michael Wonder on 01 Aug 2025
FDA approves Alhemo as once daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with haemophilia A or B without inhibitors
31 July 2025 - FDA approval is based on phase 3 trial data (explorer8), which established the safety and efficacy of ...
Posted by Michael Wonder on 01 Aug 2025
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel (tab-cel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
24 July 2025 - PDUFA target action date of 10 January 2026. ...
Posted by Michael Wonder on 01 Aug 2025
Lenz Therapeutics announces US FDA approval of Vizz for the treatment of presbyopia
31 July 2025 - Vizz samples and product availability in the US expected as early as October 2025. ...
Posted by Michael Wonder on 01 Aug 2025
Novartis twice yearly Leqvio (inclisiran) receives FDA approval for new indication enabling first-line use
31 July 2025 - 4 out of 5 atherosclerotic cardiovascular disease patients do not reach guideline-recommended LDL-C target, reinforcing urgent need ...
Posted by Michael Wonder on 01 Aug 2025
US FDA approves new Biktarvy indication for people with HIV who are treatment experienced and restarting antiretroviral treatment
30 July 2025 - Gilead Sciences today announced that the US FDA has granted a new approval for a novel ...
Posted by Michael Wonder on 31 Jul 2025
Revalesio receives FDA fast track designation for RNS60 for the treatment of acute ischaemic stroke
31 July 2025 - Revalesio today announced that the US FDA has granted fast track designation to RNS60, its lead investigational ...
Posted by Michael Wonder on 30 Jul 2025
Johnson & Johnson files with US FDA to include new evidence in Tremfya (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis
29 July 2025 - Submission is supported by 24 week results from the Phase 3b APEX study in adults with active ...
Posted by Michael Wonder on 30 Jul 2025
Calidi Biotherapeutics receives FDA fast track designation for CLD-201 (SuperNova), a first in class stem cell loaded viral therapy for the treatment of patients with soft tissue sarcoma
29 July 2025 - Calidi Biotherapeutics today announced that it received fast track designation from the US FDA for CLD-201 (SuperNova), ...
Posted by Michael Wonder on 30 Jul 2025
Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of severe to very severe alopecia areata
29 July 2025 - Nektar Therapeutics today announced that the US FDA has granted fast track designation for rezpegaldesleukin for the ...
Posted by Michael Wonder on 29 Jul 2025
AbbVie submits for US FDA approval of combination treatment of Venclexta (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukaemia
29 July 2025 - Application is supported by data from the Phase 3 AMPLIFY trial that showed statistically significant improvement in ...
Posted by Michael Wonder on 29 Jul 2025
FDA approves Apellis’ Empaveli (pegcetacoplan) as the first C3G and primary IC-MPGN treatment for patients 12 and older
28 July 2025 - Broad label includes adults and adolescents with C3G or primary IC-MPGN, and post-transplant C3G disease recurrence. ...
Posted by Michael Wonder on 29 Jul 2025
PTC Therapeutics announces FDA approval of Sephience (sepiapterin) for the treatment of children and adults living with phenylketonuria
28 July 2025 - Broad labelling inclusive of all disease subtypes for individuals 1 month of age and older. ...
Posted by Michael Wonder on 29 Jul 2025
FDA approves Skytrofa (lonapegsomatropin-tcgd) for the once weekly treatment of adults with growth hormone deficiency
28 July 2025 - On track to initiate basket trial for idiopathic short stature, SHOX deficiency, Turner syndrome, and short ...
Posted by Michael Wonder on 28 Jul 2025
MAIA Biotechnology receives FDA’s fast track designation for ateganosine as a treatment for non-small cell lung cancer
28 July 2025 - Potential first to market small molecule telomere targeting agent targets a $34 billion non-small cell lung cancer ...