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RSS FeedPosted by Michael Wonder on 18 Mar 2024
FDA approves first gene therapy for children with metachromatic leukodystrophy
18 March 2024 - Today, the US FDA approved Lenmeldy (atidarsagene autotemcel), the first FDA approved gene therapy indicated for the ...
Posted by Michael Wonder on 18 Mar 2024
Xhance approved by FDA as first and only medication indicated for treatment of adults with chronic rhinosinusitis without nasal polyps
15 March 2024 - ReOpen was the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms ...
Posted by Michael Wonder on 18 Mar 2024
Zymfentra (infliximab-dyyb), the first and only FDA approved subcutaneous infliximab, now commercially available in the U.S.
17 March 2024 - Zymfentra is commercially available across the US on 15 March 2024. ...
Posted by Michael Wonder on 17 Mar 2024
BeiGene receives FDA approval for Tevimbra for the treatment of advanced or metastatic oesophageal squamous cell carcinoma after prior chemotherapy
14 March 2024 - Results from the global, Phase 3 RATIONALE 302 trial showed Tevimbra prolonged the survival of patients who ...
Posted by Michael Wonder on 16 Mar 2024
ImmVira's oncolytic product MVR-T3011 IT intratumoral injection receives FDA fast track designation for HNSCC treatment
15 March 2024 - ImmVira has recently announced that the US FDA has granted fast track designation for oncolytic virus product ...
Posted by Michael Wonder on 15 Mar 2024
US FDA approves Bristol Myers Squibb’s Breyanzi as the first and only CAR T cell therapy for adults with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
14 March 2024 - In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in ...
Posted by Michael Wonder on 14 Mar 2024
Keros Therapeutics announces US FDA fast track designation for KER-050 in lower-risk myelodysplastic syndromes
14 March 2024 - Keros Therapeutics today announced that the US FDA has granted fast track designation for KER-050 (elritercept) for ...
Posted by Michael Wonder on 14 Mar 2024
FDA approves first treatment for patients with liver scarring due to fatty liver disease
14 March 2024 - Today, the US FDA approved Rezdiffra (resmetirom) for the treatment of adults with non-cirrhotic non-alcoholic steatohepatitis with ...
Posted by Michael Wonder on 14 Mar 2024
PepGen receives US FDA orphan drug and rare paediatric disease designations for PGN-EDO51 for the treatment of Duchenne muscular dystrophy
13 March 2024 - PepGen today announced that the US FDA granted both orphan drug and rare paediatric disease designations for ...
Posted by Michael Wonder on 14 Mar 2024
Cybin receives FDA breakthrough therapy designation for its novel psychedelic molecule CYB003
13 March 2024 - First known breakthrough therapy designation granted by the FDA for an adjunctive psychedelic based therapy for the ...
Posted by Michael Wonder on 12 Mar 2024
Johnson & Johnson submits supplemental biologics license application to US FDA seeking approval of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis
11 March 2024 - Submission is supported by data from the Phase 3 QUASAR program, which showed a significantly greater percentage ...
Posted by Michael Wonder on 12 Mar 2024
Travere Therapeutics submits supplemental new drug application to the US FDA seeking full approval of Filspari (sparsentan) for the treatment of IgA nephropathy
11 March 2024 - Submission is based on 2 year confirmatory results from the Phase 3 PROTECT study in which Filspari ...
Posted by Michael Wonder on 12 Mar 2024
Viatris and Mapi Pharma statement regarding new drug application for glatiramer acetate depot
11 March 2024 - Viatris has been informed that Mapi Pharma has received a complete response letter regarding the new drug ...
Posted by Michael Wonder on 11 Mar 2024
Praluent (alirocumab) injection receives FDA approval to treat children with genetic form of high cholesterol
11 March 2024 - Approval extends treatment of Praluent to children aged 8 and older with heterozygous familial hypercholesterolaemia. ...
Posted by Michael Wonder on 11 Mar 2024
Celltrion USA completes submission of biologics license application to US FDA for CT-P39, an interchangeable biosimilar candidate of Xolair (omalizumab)
10 March 2024 - The BLA for CT-P39 was based on totality of evidence including results from Phase III data ...