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RSS FeedPosted by Michael Wonder on 27 Mar 2026
Awiqli approved in the US, the first and only once weekly basal insulin treatment for adults with type 2 diabetes
27 March 2026 - Novo Nordisk expects to launch Awiqli nationwide in the US in the second half of 2026. ...
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 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 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 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 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 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 ...