Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 28 Jul 2025
Imfinzi granted priority review and breakthrough therapy designation in the US for patients with resectable early-stage gastric and gastro-oesophageal junction cancers
28 July 2025 - Based on MATTERHORN Phase 3 trial results which demonstrated a statistically significant and clinically meaningful event-free survival ...
Posted by Michael Wonder on 26 Jul 2025
Sobi announces US FDA approves Doptelet (avatrombopag) for the treatment of thrombocytopenia in paediatric patients one year and older with persistent or chronic immune thrombocytopenia
25 July 2025 - The primary outcome was met in 27.8% of patients, confirming the efficacy in children and adolescents ...
Posted by Michael Wonder on 26 Jul 2025
Shanton receives fast track designation from US FDA for refractory gout program
25 July 2025 - Shanton Pharma today announced that FDA has designated its Investigational new drug SAP-001 as a fast track ...
Posted by Michael Wonder on 26 Jul 2025
Bayer provides regulatory update on elinzanetant in the US
25 July 2025 - Bayer today announced that the US FDA has notified the company that it has extended the ...
Posted by Michael Wonder on 25 Jul 2025
FDA grants priority review for Addyi (flibanserin) paving the way for expanded access to treat low sexual desire in post-menopausal women
24 July 2025 - Sprout Pharmaceuticals today announced that the US FDA has granted priority review for its supplemental application ...
Posted by Michael Wonder on 24 Jul 2025
Verastem Oncology granted fast track designation for VS-7375 for the treatment of KRAS G12D mutated locally advanced or metastatic pancreatic cancer
24 July 2025 - Enrollment is on-going in US Phase 1/2a trial for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, ...
Posted by Michael Wonder on 24 Jul 2025
Commissioner's National Priority Voucher Pilot Program
22 July 2025 - Accelerated drug review for companies supporting US national interests. ...
Posted by Michael Wonder on 24 Jul 2025
Avidity Biosciences receives FDA breakthrough therapy designation for delpacibart zotadirsen for the treatment of DMD in people with mutations amenable to exon 44 skipping
23 July 2025 - On track for planned BLA submission for delpacibart zotadirsen at year end 2025. ...