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RSS FeedPosted by Michael Wonder on 27 Mar 2026
Norgine announces Swissmedic approval of Pedmarqsi for the prevention of cisplatin induced hearing loss in children
26 March 2026 - The data from 2 open-label, randomised Phase 3 trials, SIOPEL 6 (pivotal) and the Clinical Oncology Group ...
Posted by Michael Wonder on 27 Mar 2026
FDA approves first gene therapy for severe leukocyte adhesion deficiency type I
26 March 2026 - The US FDA today approved Kresladi (marnetegragene autotemcel), the first gene therapy for the treatment of severe ...
Posted by Michael Wonder on 26 Mar 2026
UCB receives positive CHMP opinion for new Zilbrysq (zilucoplan) pre-filled pen in EU for adults living with generalised myasthenia gravis
26 March 2026 - UCB today announced that the CHMP of the EMA has issued a positive opinion recommending a ...
Posted by Michael Wonder on 26 Mar 2026
Apotex expands Canadian ophthalmology portfolio with Health Canada's approval of Clobivis (clobetasol propionate ophthalmic suspension, 0.05%)
25 March 2026 - Apotex today announced that Health Canada has approved Clobivis (clobetasol propionate ophthalmic suspension, 0.05%), indicated for ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves drug to treat neurologic manifestations of Hunter syndrome
25 March 2026 - The US FDA approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (mucopolysaccharidosis type II ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
25 March 2026 - Today, the FDA approved relacorilant (Lifyorli, Corcept Therapeutics), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel ...
Posted by Michael Wonder on 24 Mar 2026
Dupixent (dupilumab) approved in Japan as the first targeted medicine to treat adults with bullous pemphigoid
24 March 2026 - Bullous pemphigoid is the seventh approved indication for Dupixent in Japan ...
Posted by Michael Wonder on 23 Mar 2026
Enhertu approved in Japan as first tumour agnostic HER2 directed medicine for previously treated patients with HER2 positive metastatic solid tumours
23 March 2026 - Based on four Phase 2 trials where Enhertu demonstrated clinically meaningful responses across a broad range ...
Posted by Michael Wonder on 20 Mar 2026
Bristol Myers Squibb transforms the classical Hodgkin lymphoma treatment paradigm with expanded US and EMA approvals for Opdivo (nivolumab)
20 March 2026 - Bristol Myers Squibb today announced that Opdivo (nivolumab) has received approval for two new classical Hodgkin ...
Posted by Michael Wonder on 20 Mar 2026
Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for patients with acquired hypothalamic obesity
19 March 2026 - Rhythm Pharmaceuticals today announced that the US FDA has approved an expanded indication for Imcivree (setmelanotide) to ...
Posted 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 ...