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RSS FeedPosted by Michael Wonder on 19 Mar 2024
Citius Pharmaceuticals announces FDA acceptance of the BLA resubmission of Lymphir (denileukin diftitox) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
18 March 2024 - FDA assigns Prescription Drug User Fee Act target action date of 13 August 2024 ...
Posted by Michael Wonder on 18 Mar 2024
EMA publishes agenda for 18-21 March 2024 CHMP meeting
18 March 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted 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 15 Mar 2024
Bimzelx (bimekizumab) now approved for adults with active psoriatic arthritis and for adults with axial spondyloarthritis
14 March 2024 - Health Canada's approval is supported by Phase III clinical trial data which found Bimzelx provided significant improvement ...
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 14 Mar 2024
European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
13 March 2024 - Prevenar 20 (20 valent pneumococcal conjugate vaccine) offers the broadest serotype coverage of any paediatric pneumococcal ...
Posted by Michael Wonder on 13 Mar 2024
Sumitomo Pharma announces availability of Orgovyx (relugolix) in Canada, the first and only oral androgen deprivation therapy treatment for men with advanced prostate cancer
12 March 2024 - Sumitomo Pharma announced today that Orgovyx (relugolix), an oral gonadotropin-releasing hormone receptor antagonist, is now available for ...