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RSS FeedPosted 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
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
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
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 ...
Posted by Michael Wonder on 06 Oct 2025
Amgen makes Repatha available though AmgenNow, a direct to patient program in the US
6 October 2025 - Eligible patients can access Repatha at nearly 60% discount from the list price. ...
Posted by Michael Wonder on 05 Oct 2025
Why Pfizer’s Trump deal is good news for all of big pharma
2 October 2025 - The company’s accord with the president clears a cloud over the whole sector. ...
Posted by Michael Wonder on 04 Oct 2025
Alzinova receives fast track designation from US FDA for ALZ-101 in Alzheimer’s disease
4 October 2025 - Alzinova today announces that the US FDA has granted fast track designation for the company’s vaccine candidate ...
Posted by Michael Wonder on 04 Oct 2025
Ensem Therapeutics announces ETX-636 granted fast track designation by the FDA for advanced breast cancer
1 October 2025 - Ensem Therapeutics today announced the US FDA granted fast track designation to its clinical stage pan mutant-specific ...
Posted by Michael Wonder on 04 Oct 2025
Does big pharma gouge Americans?
2 October 2025 - In the bloated health care system, others are the real money makers. ...