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RSS FeedPosted 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 23 Mar 2026
Ionis announces zilganersen new drug application for Alexander disease accepted by FDA for priority review
23 March 2026 - Ionis Pharmaceuticals today announced that the US FDA has accepted for priority review the new drug application ...
Posted by Michael Wonder on 22 Mar 2026
IntraBio announces submission of supplemental new drug application for levacetylleucine for ataxia-telangiectasia
20 March 2026 - IntraBio today announced the submission of a supplemental new drug application to the US FDA for ...
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 18 Mar 2026
Aldeyra Therapeutics receives complete response letter from the US Food and Drug Administration for the reproxalap new drug application for the treatment of signs and symptoms of dry eye disease
17 March 2026 - Aldeyra Therapeutics today announced receipt of a complete response letter from the US FDA for the new ...
Posted by Michael Wonder on 17 Mar 2026
Sun Pharma announces US FDA acceptance of supplemental biologics license application for Ilumya (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis
16 March 2026 - Sun Pharmaceutical Industries announced that the US FDA has accepted for review the supplemental biologics license ...
Posted by Michael Wonder on 16 Mar 2026
Cogent Biosciences announces FDA acceptance of new drug application for bezuclastinib in patients with non-advanced systemic mastocytosis
16 March 2026 - NDA based on positive clinical results from the SUMMIT pivotal trial in which bezuclastinib demonstrated clear clinical ...