Blog
RSS FeedPosted by Michael Wonder on 15 Oct 2025
Roche's Elecsys pTau181 becomes the only FDA cleared blood test for use in primary care to rule out Alzheimer's related amyloid pathology
13 October 2025 - Roche today announced that the US FDA has cleared its Elecsys pTau181 test, the only blood ...
Posted by Michael Wonder on 13 Oct 2025
US FDA approves updated indication statement for Rinvoq (upadacitinib) for the treatment of inflammatory bowel disease
13 October 2025 - Updated indication allows the use of Rinvoq (upadacitinib) prior to the use of tumour necrosis factor blocking ...
Posted by Michael Wonder on 11 Oct 2025
SQ Innovation announces FDA approval of Lasix ONYU for treatment of edema in heart failure
8 October 2025 - -- SQ Innovation today announced that the US FDA has approved its drug-device combination Lasix ONYU ...
Posted by Michael Wonder on 10 Oct 2025
FDA approves expanded indication for Uzedy (risperidone) extended release injectable suspension as a treatment for adults living with bipolar I disorder
10 October 2025 - Teva Pharmaceuticals announced today that the US FDA has approved Uzedy (risperidone) as a once-monthly extended-release injectable ...
Posted by Michael Wonder on 10 Oct 2025
Celltrion receives US FDA approval for Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept)
9 October 2025 - Celltrion today announced that the US FDA has approved Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept), for the ...
Posted by Michael Wonder on 10 Oct 2025
US FDA approves Boehringer’s Jascayd (nerandomilast tablets) as first new treatment option for adults with IPF in over a decade
9 October 2025 - Approval is based on results from two clinical trials, which showed reduction in forced vital capacity decline ...
Posted by Michael Wonder on 09 Oct 2025
Richter and Hikma receive FDA approval for denosumab biosimilars Enoby and Xtrenbo, referencing Prolia and Xgeva
29 September 2025 - Gedeon Richter and Hikma Pharmaceuticals announce today that the US FDA has granted approval for the ...
Posted by Michael Wonder on 08 Oct 2025
Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval
8 October 2025 - Xspray Pharma has received a complete response letter from the US FDA concerning the Company’s new ...
Posted by Michael Wonder on 08 Oct 2025
FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma
8 October 2025 - Today, the FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals) for the adjuvant treatment of adults with cutaneous ...
Posted by Michael Wonder on 08 Oct 2025
US FDA approves Simponi (golimumab) for the treatment of paediatric ulcerative colitis
7 October 2025 - Johnson & Johnson today announced that the US FDA has approved Simponi (golimumab) for the treatment of ...
Posted by Michael Wonder on 07 Oct 2025
FDA approves Arcutis’ Zoryve (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5
6 October 2025 - Commercial product expected to be available by the end of October 2025. ...
Posted by Michael Wonder on 03 Oct 2025
FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer
2 October 2025 - Today, the FDA approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals) in combination with atezolizumab (Tecentriq) or atezolizumab and ...
Posted by Michael Wonder on 30 Sep 2025
Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria
30 September 2025 - Remibrutinib also in clinical development for chronic inducible urticaria, food allergy, and hidradenitis suppurativa, expanding Novartis Immunology ...
Posted by Michael Wonder on 30 Sep 2025
FDA approves Guardant360 CDx as companion diagnostic for Eli Lilly and Company’s Inluriyo (imlunestrant) for treatment of ESR1 mutated advanced breast cancer
29 September 2025 - This marks the second FDA approved indication for Guardant360 CDx as a companion diagnostic in breast cancer ...
Posted by Michael Wonder on 30 Sep 2025
Kedrion Biopharma receives FDA approval for Qivigy (immune globulin 10% IV) for treatment of primary humoral immunodeficiency in Adults
29 September 2025 - Kedrion Biopharma announced today that it has received FDA approval for Qivigy immune globulin intravenous (human)-kthm 10% ...