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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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Co-design of an enhanced consumer engagement process

18 March 2024 - A consumer-led Co-design Working Group has developed proposed recommendations for enhancing consumer engagement processes to enable ...

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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. ...

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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 ...

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Funding process for child cancer medicines to remain

15 March 2024 - Pharmac has decided to keep Rule 8.1b, which allows medicines for treating children with cancer to ...

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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 ...

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Public Summary Documents (first time rejections and deferrals) – November 2023 PBAC meeting

15 March 2024 - The Public Summary Documents (first time decisions not to recommend and deferrals) from the November 2023 PBAC ...

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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 ...

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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 ...

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State coverage and reimbursement of anti-obesity medications in Medicaid

14 March 2024 - Medicare Part D plans statutorily cannot cover anti-obesity medications, but state Medicaid programs have more flexibility. ...

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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 ...

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