Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 15 Apr 2025
Health Canada approves Nduvra (tapinarof 1% cream) for the topical treatment of plaque psoriasis in adults
14 April 2025 - Organon today announced that Health Canada has approved Nduvra (tapinarof cream), 1%, the first in a novel ...
Posted by Michael Wonder on 14 Apr 2025
SynOx Therapeutics receives fast track designation from US FDA for emactuzumab for tenosynovial giant cell tumours
14 April 2025 - SynOx Therapeutics today announced that the US FDA has granted fast track designation to emactuzumab for the ...
Posted by Michael Wonder on 14 Apr 2025
European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy
14 April 2025 - Approval based on Phase 3 STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction ...
Posted by Michael Wonder on 14 Apr 2025
Thousands of people a year could benefit from new twice a day tablet for advanced breast cancer
11 April 2025 - We've published final draft guidance recommending capivasertib with fulvestrant, which means the treatment will be funded immediately ...
Posted by Michael Wonder on 12 Apr 2025
Public Summary Documents – December 2024 PBAC meeting
11 April 2025 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the December 2024 PBAC ...
Posted by Michael Wonder on 11 Apr 2025
Verve Therapeutics receives US FDA fast track designation for VERVE-102, an in vivo base editing medicine targeting PCSK9
11 April 2025 - Verve Therapeutics today announced that the US FDA has granted fast track designation for VERVE-102 for ...
Posted by Michael Wonder on 11 Apr 2025
FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma
11 April 2025 - Today, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, ...
Posted by Michael Wonder on 11 Apr 2025
US FDA grants full approval of Vitrakvi (larotrectinib) for adult and paediatric patients with NTRK gene fusion-positive solid tumours
10 April 2025 - The full approval of Vitrakvi is based on the results of confirmatory trials that support Vitrakvi as ...
Posted by Michael Wonder on 11 Apr 2025
argenx announces FDA approval of Vyvgart Hytrulo pre-filled syringe for self-injection in generalised myasthenia gravis and chronic inflammatory demyelinating polyneuropathy
10 April 2025 - Self-injection provides generalised myasthenia gravis and chronic inflammatory demyelinating polyneuropathy patients with flexibility for when and where to receive ...
Posted by Michael Wonder on 11 Apr 2025
Health Canada approves Imfinzi (durvalumab) as the first and only immunotherapy regimen for adult patients with limited-stage small cell lung cancer
10 April 2025 - Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab), as monotherapy, for the treatment ...
Posted by Michael Wonder on 11 Apr 2025
Biocon Biologics announces US FDA approval for Jobevne, biosimilar bevacizumab
10 April 2025 - Biocon Biologics today announced that the US FDA has approved Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab for ...
Posted by Michael Wonder on 11 Apr 2025
13,000 people to benefit from new insulin medicine
11 April 2025 - Pharmac will fund a new type of insulin for people with diabetes, branded as Ryzodeg, from ...
Posted by Michael Wonder on 10 Apr 2025
Trastuzumab deruxtecan approved to treat adults with HER2-positive cancer that has spread or cannot be removed by surgery
9 April 2025 - The MHRA has today approved trastuzumab deruxtecan (Enhertu) to treat people with solid tumours that have ...
Posted by Michael Wonder on 10 Apr 2025
Arcturus Therapeutics receives US FDA fast track designation for the STARR mRNA vaccine candidate ARCT-2304 for pandemic influenza A virus H5N1
10 April 2025 - Arcturus Therapeutics today announced that the US FDA has granted fast track designation for the self-amplifying mRNA ...
Posted by Michael Wonder on 10 Apr 2025
Pfizer wins Korea nod for paediatric arthritis use of oral JAK inhibitor Xeljanz
7 April 2025 - Pfizer Korea has won national reimbursement for its oral JAK inhibitor Xeljanz (tofacitinib), expanding access to ...