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RSS FeedPosted by Michael Wonder on 03 Oct 2025
Bristol Myers Squibb plans to launch Cobenfy (xanomeline and trospium chloride) in the UK at a list price equal to the US launch price
22 September 2025 - Bristol Myers Squibb plans to launch Cobenfy (xanomeline and trospium chloride), in the UK in 2026. ...
Posted by Michael Wonder on 03 Oct 2025
Health Canada approves Agamree (vamorolone) as the first treatment for Duchenne muscular dystrophy in Canada
2 October 2025 - Kye Pharmaceuticals announced today that Health Canada has approved Agamree (vamorolone) for the treatment of Duchenne muscular ...
Posted by Michael Wonder on 03 Oct 2025
Nacuity Pharmaceuticals granted US FDA breakthrough therapy designation for NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa
2 October 2025 - Nacuity Pharmaceuticals today announced that the US FDA has granted breakthrough therapy designation to NPI-001 (N-acetylcysteine amide) ...
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 02 Oct 2025
Calico Life Sciences announces US FDA fast track designation for investigational treatment of autosomal dominant polycystic kidney disease
2 October 2025 - Calico Life Sciences today announced the US FDA granted fast track designation for ABBV-CLS-628, an investigational therapy ...
Posted by Michael Wonder on 02 Oct 2025
PHARMAC proposes changes to make it easier to access HIV medicines
1 October 2025 - New Zealanders living with, or at risk of, HIV could soon benefit from proposed changes to ...
Posted by Michael Wonder on 02 Oct 2025
Wockhardt submits new drug application to US FDA for zidebactam-cefepime (WCK 5222) for treatment of serious gram-negative infections
1 October 2025 - Wockhardt today announced the submission of new drug application to the US FDA for its novel ...
Posted by Michael Wonder on 02 Oct 2025
TAHO Pharma announces submission of new drug application to the US FDA for TAH3311 – the world’s first apixaban oral dissolving film – represents a transformational advancement in anti-coagulant therapy
30 September 2025 - TAHO Pharmaceuticals today announced the submission of its new drug application to the US FDA for TAH3311, ...
Posted by Michael Wonder on 02 Oct 2025
Pharming Group announces US FDA acceptance and priority review of supplemental new drug application for leniolisib in children with APDS aged 4 to 11 years
1 October 2025 - Pharming today announced that the US FDA has accepted its supplemental new drug application seeking approval for ...
Posted by Michael Wonder on 02 Oct 2025
Organon Canada announces the availability of Nduvra (1% tapinarof cream) for the topical treatment of plaque psoriasis in adults
1 October 2025 - Organon Canada announces the availability of Ndruvra (1% tapinarof cream) for the topical treatment of plaque psoriasis ...
Posted by Michael Wonder on 01 Oct 2025
Sentynl Therapeutics updates on its NDA for CUTX-101
1 October 2025 - Sentynl Therapeutics announced today that the US FDA has issued a complete response letter relating to ...
Posted by Michael Wonder on 01 Oct 2025
Bristol Myers Squibb’s anti-MTBR-tau targeting antibody, BMS-986446, granted fast track designation by US FDA for the treatment of Alzheimer’s disease
1 October 2025 - Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of ...
Posted by Michael Wonder on 01 Oct 2025
Enhertu followed by THP supplemental biologics license application accepted in the US for patients with high risk HER2 positive early stage breast cancer prior to surgery
1 October 2025 - Based on results from DESTINY-Breast11, the first Phase 3 trial to demonstrate benefit of Daiichi Sankyo ...
Posted by Michael Wonder on 01 Oct 2025
White House unveils ‘TrumpRx’ drug buying site and a Pfizer pricing deal
30 September 2025 - The company says it gains a three year grace period to exempt it from national-security-related tariffs. ...
Posted by Michael Wonder on 01 Oct 2025
Imfinzi’s bid for coverage faces Keytruda’s double-edged impact in Korea
30 September 2025 - AstraZeneca's immuno-oncology drug Imfinzi (durvalumab) is attempting to expand its reimbursement coverage, but its competitor, MSD's ...