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RSS FeedPosted 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
Johnson & Johnson to offer four prescription medicines on TrumpRx website
24 April 2026 - Johnson & Johnson will start selling four of its medications on the Trump administration's TrumpRx website, ...
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 ...
Posted by Michael Wonder on 30 Apr 2026
Immunome nnounces submission of new drug application to US FDA for varegacestat for the treatment of adults with desmoid tumours
29 April 2026 - Immunome today announced the submission of a new drug application to the US FDA for varegacestat, an ...
Posted by Michael Wonder on 30 Apr 2026
ICER releases evidence report on treatment for narcolepsy
29 April 2026 - Oveporexton provides a net health benefit compared to currently available treatments; therapy would be cost effective ...
Posted by Michael Wonder on 30 Apr 2026
US FDA grants priority review of new drug application for Gilead’s once daily HIV treatment of bictegravir plus lenacapavir
29 April 2026 - Gilead Sciences today announced the US FDA accepted its new drug application submission for bictegravir 75 mg/lenacapavir ...