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RSS FeedPosted by Michael Wonder on 07 May 2026
Diakonos Oncology awarded fast track designation by FDA for DOC1021 (dubodencel) in unresectable or metastatic cutaneous melanoma
6 May 2026 - Diakonos Oncology announced today that the US FDA has granted fast track designation to DOC1021, the ...
Posted by Michael Wonder on 06 May 2026
Guardant Health receives FDA approval for Guardant360 CDx as a companion diagnostic for Arvinas and Pfizer’s Veppanu (vepdegestrant) for patients with ER+/HER2- advanced breast cancer with ESR1 mutations
4 May 2026 - Guardant Health today announced that the US FDA has approved the Guardant360 CDx liquid biopsy test ...
Posted by Michael Wonder on 05 May 2026
FDA grants fast track designation for CS-1103, a first in class small molecule to reverse acute intoxication from fentanyl
5 May 2026 - Clear Scientific announced today that the US FDA has granted its lead asset, CS-1103, fast track designation ...
Posted by Michael Wonder on 05 May 2026
Spinogenix receives US FDA fast track designation for tazbentetol for the treatment of ALS
5 May 2026 - Spinogenix today announced that the US FDA has granted fast track designation to tazbentetol for the ...
Posted by Michael Wonder on 05 May 2026
Satellite Bio announces FDA rare paediatric disease designation for SB-101 for the treatment of urea cycle disorders
4 May 2026 - Satellite Biosciences today announced that the US FDA has granted rare paediatric disease designation for SB-101 for ...
Posted by Michael Wonder on 05 May 2026
Atossa Therapeutics receives FDA rare paediatric disease designation for (Z)-endoxifen for McCune-Albright syndrome
4 May 2026 - Atossa Therapeutics today announced that the US FDA has granted rare paediatric disease designation to (Z)-endoxifen for ...
Posted by Michael Wonder on 03 May 2026
US pushes real time clinical trials to eliminate “dead time” in approvals
1 May 2026 - The US FDA is testing “real time clinical trials,” which it says will provide faster access ...
Posted by Michael Wonder on 03 May 2026
Incyte announces FDA Approval of Jakafi XR (ruxolitinib) extended release tablets for the treatment of myelofibrosis, polycythemia vera and graft versus host disease
1 May 2026 - Jakafi XR will be available for pharmacy orders by 8 May 2026. ...
Posted by Michael Wonder on 02 May 2026
Stelara paediatric Crohn’s disease FDA approval J&J statement
1 May 2026 - On 15 April 2026, the US FDA approved Stelara (ustekinumab) for the treatment of patients two ...
Posted by Michael Wonder on 01 May 2026
FDA approves vepdegestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer
1 May 2026 - Today, the FDA approved vepdegestrant (Veppanu, Arvinas), a heterobifunctional protein degrader, for adults with oestrogen receptor ...
Posted by Michael Wonder on 01 May 2026
FDA approves first non-antipsychotic drug to treat agitation associated with dementia
30 April 2026 - The US FDA today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets ...
Posted by Michael Wonder on 01 May 2026
MRM Health’s lead candidate MH002 granted fast track designation by US FDA for the treatment of mild to moderate ulcerative colitis
30 April 2026 - MRM Health today announced that MH002, the Company’s lead rationally designed live biotherapeutic product candidate, has been ...
Posted by Michael Wonder on 30 Apr 2026
Prolong’s investigational therapy for acute ischaemic stroke, PP-007, receives FDA breakthrough therapy designation
30 April 2026 - Prolong Pharmaceuticals announced today that its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), has received breakthrough therapy designation ...
Posted by Michael Wonder on 30 Apr 2026
Xbrane submits ranibizumab biosimilar candidate to FDA
29 April 2026 - Xbrane Biopharma has submitted an application for approval to the US FDA for its biosimilar candidate ...
Posted by Michael Wonder on 30 Apr 2026
US FDA grants priority review to BeOne Medicines’ Tevimbra in first-line HER2 positive gastro-oesophageal adenocarcinoma
29 April 2026 - BeOne Medicines today announced that the US FDA has granted priority review to a supplemental biologics ...