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RSS FeedPosted by Michael Wonder on 20 Mar 2026
FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma
20 March 2026 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine for ...
Posted by Michael Wonder on 20 Mar 2026
Public summary documents (first time decisions not to recommend and deferrals) – November 2025 PBAC meeting
20 March 2026 - The Public Summary Documents (first time decisions not to recommend and deferrals) from the November 2025 PBAC ...
Posted by Michael Wonder on 19 Mar 2026
FDA approves fourth product under National Priority Voucher Program, higher dose semaglutide
19 March 2026 - The US FDA today approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection, called Wegovy ...
Posted by Michael Wonder on 19 Mar 2026
Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis
19 March 2026 - Approval based on the positive GLISTEN Phase 3 trial with regulatory reviews underway in the EU, ...
Posted by Michael Wonder on 19 Mar 2026
Myriad Genetics receives FDA approval of the MyChoice CDx test as the companion diagnostic for Zejula (niraparib) for patients with ovarian cancer
17 March 2026 - Approval reinforces Myriad’s leadership in comprehensive HRD testing and establishes MyChoice CDx as the only FDA-approved ...
Posted by Michael Wonder on 18 Mar 2026
FDA approval of Icotyde (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide
18 March 2026 - Johnson & Johnson introduces the first and only IL-23R targeted oral peptide that delivers complete skin clearance ...
Posted by Michael Wonder on 18 Mar 2026
FDA issues a complete response letter regarding the NDA for idebenone for Leber hereditary optic neuropathy in the United States
5 March 2026 - Idebenone remains marketed in multiple countries outside the US as a treatment for Leber hereditary optic neuropathy. ...
Posted by Michael Wonder on 16 Mar 2026
Imfinzi approved in the EU as first and only peri-operative immunotherapy for patients with early gastric and gastro-oesophageal cancers
16 March 2026 - Approval based on MATTERHORN Phase 3 trial demonstrating statistically significant and clinically meaningful improvements in event-free ...
Posted by Michael Wonder on 13 Mar 2026
Novartis Cosentyx receives FDA approval for paediatric patients aged 12+ with moderate to severe hidradenitis suppurativa
13 March 2026 - Novartis announced today that Cosentyx (secukinumab) received US FDA approval for treating paediatric patients 12 years ...
Posted by Michael Wonder on 13 Mar 2026
GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk
13 March 2026 - GSK today announced that the US FDA has expanded the approved age indication of Arexvy (respiratory syncytial ...
Posted by Michael Wonder on 13 Mar 2026
MHRA approves deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults
12 March 2026 - The MHRA has approved deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults. ...
Posted by Michael Wonder on 12 Mar 2026
500,000 eligible to benefit from new non-hormonal treatment for hot flushes caused by menopause
11 March 2026 - A new treatment option for menopausal hot flushes and night sweats can be used in the NHS ...
Posted by Michael Wonder on 10 Mar 2026
FDA approves first treatment for patients with cerebral folate transport deficiency
10 March 2026 - The US FDA today approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of ...
Posted by Michael Wonder on 10 Mar 2026
Koselugo approved in Canada for plexiform neurofibromas in adults with neurofibromatosis type 1
9 March 2026 - Approval based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...
Posted by Michael Wonder on 08 Mar 2026
Incyte announces the European Commission approval of Zynyz (retifanlimab) for the first-line treatment of advanced squamous cell carcinoma of the anal canal
6 March 2026 - The EC approval is based on results of the POD1UM-303 study which showed that adult patients with ...