Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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
Werewolf Therapeutics receives fast track designation from the US FDA for WTX-124, an investigational therapy for the treatment of cancer
8 October 2025 - Werewolf Therapeutics today announced that the Company has received fast track designation for the use of WTX-124 ...
Posted by Michael Wonder on 08 Oct 2025
Vivace Therapeutics' VT3989 granted fast track designation by the US FDA for the treatment of mesothelioma
8 October 2025 - Vivace Therapeutics today announced that the US FDA has granted fast track designation to VT3989, the company's ...
Posted by Michael Wonder on 08 Oct 2025
Britain prepares NHS drug spending hike to stave off Trump tariffs
8 October 2025 - The UK Government has drawn up proposals to increase the amount the National Health Service pays ...
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
Ontario connecting patients to life-saving cancer drugs faster
7 October 2025 - The Ontario Government is leading the world in cancer care by launching the Funding Accelerated for ...
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
Enhertu plus pertuzumab supplemental new drug application submitted in Japan as first-line therapy for patients with HER2 positive metastatic breast cancer
7 October 2025 - Submission based on DESTINY-Breast09 Phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk ...
Posted by Michael Wonder on 07 Oct 2025
Jesse's dad, who walked Canada for his son, cheers approval of new Duchenne drug
3 October 2025 - Vamorolone is the first Health Canada approved drug developed specifically to treat Duchenne. ...
Posted by Michael Wonder on 07 Oct 2025
Kashiv Biosciences announces submission of biologics license application to US FDA and acceptance of market authorisation application by EMA for ADL-018, a proposed biosimilar to Xolair (omalizumab)
6 October 2025 - Kashiv BioSciences announced that they have submitted a biologics license application to the US FDA, and ...
Posted by Michael Wonder on 07 Oct 2025
Orca Bio announces FDA acceptance and priority review of the biologics license application for Orca-T to treat haematological malignancies
6 October 2025 - FDA assigns PDUFA target action date of 6 April 2026. ...
Posted by Michael Wonder on 07 Oct 2025
European marketing application for AVT23, a proposed biosimilar to Xolair (omalizumab), accepted by the EMA
6 October 2025 - Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT23, a proposed ...
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 07 Oct 2025
Spruce Biosciences receives US FDA breakthrough therapy designation for tralesinidase alfa enzyme replacement therapy in Sanfilippo syndrome type B
6 October 2025 - Breakthrough therapy designation supported by integrated long-term clinical data demonstrating normalisation in cerebral spinal fluid heparan sulphate ...
Posted by Michael Wonder on 07 Oct 2025
EG 427 receives US FDA fast track designation for EG110A DNA medicine in neurogenic bladder patients
6 October 2025 - EG 427 announced today that the US FDA granted fast track designation to EG110A, its novel DNA ...