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RSS FeedPosted 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
Remix Therapeutics granted FDA fast track designation for REM-422 for the treatment of recurrent, metastatic or unresectable adenoid cystic carcinoma
19 March 2026 - Remix Therapeutics today announced that the US FDA has granted fast track designation to first-in-class small molecule ...
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
FluoGuide receives FDA fast track designation for FG001 in high grade glioma
18 March 2026 - FluoGuide announces that the US FDA has granted fast track designation to FG001 as an intra-operative imaging ...
Posted by Michael Wonder on 18 Mar 2026
Sanofi’s venglustat earns breakthrough therapy designation in the US for type 3 Gaucher disease
18 March 2026 - The US FDA has granted breakthrough therapy designation to venglustat, a novel, investigational oral glucosylceramide synthase ...
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
Polaryx Therapeutics receives FDA fast track designation for PLX‑200 for late‑infantile neuronal ceroid lipofuscinosis
17 March 2026 - Regulatory milestone supports advancement of the SOTERIA Phase 2 basket trial evaluating PLX‑200 across multiple lysosomal storage ...
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 17 Mar 2026
Argo Biopharma receives FDA fast track designation for BW-20805, an investigational siRNA therapy for the treatment of HAE
16 March 2026 - Global Phase 2 open-label study in adult hereditary angioedema patients on-going, company on track for primary completion ...
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 ...