Ultragenyx announces FDA acceptance and priority review of the biologics license application for UX111 AAV gene therapy to treat Sanfilippo syndrome type A

18 February 2025 - FDA decision expected by 18 August 2025. ...

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Petosemtamab granted breakthrough therapy designation by the US FDA for first-line PD-L1 positive head and neck squamous cell carcinoma

18 February 2025 - This marks the second breakthrough therapy designation for petosemtamab in head and neck squamous cell carcinoma. ...

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US FDA accepts Gilead’s new drug applications for twice yearly lenacapavir for HIV prevention under priority review

18 February 2025 - FDA to review applications under priority review, with a PDUFA date of 19 June 2025. ...

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Chimerix announces FDA acceptance and priority review of new drug application for dordaviprone as treatment for recurrent H3 K27M mutant diffuse glioma

18 February 2025 - PDUFA target action date of 18 August 2025. ...

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Dupixent (dupilumab) sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid

18 February 2025 - If approved, Dupixent would be the first and only targeted medicine to treat bullous pemphigoid in the US; ...

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Rznomics liver cancer drug candidate secures fast track designation

17 February 2025 - Second fast track designation following brain cancer approval. ...

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Platform clinical trials for the efficient evaluation of multiple treatments

17 February 2025 - For some medical conditions, including conditions without effective treatments, multiple promising but unproven therapies may exist, with ...

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Innovent receives second fast track designation from the US FDA for IBI363 (PD-1/IL-2α-bias bipspecific antibody fusion protein) in squamous non-small cell lung cancer

17 February 2025 - Innovent Biologics announced that its first in class PD-1/IL-2α-bias bi-specific antibody fusion protein, IBI363, has received its ...

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Innate Pharma announces US FDA granted breakthrough therapy designation to lacutamab for relapsed or refractory Sézary syndrome

17 February 2025 - Designation is based on TELLOMAK Phase 2 results demonstrating efficacy and a favourable safety profile in patients ...

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Out of pocket getting out of hand - reducing the financial toxicity of rapidly approved drugs

15 February 2025 - In 2023, Teresa was diagnosed with amyotrophic lateral sclerosis. Several months later, her family started a GoFundMe ...

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Cost sharing for preferred branded drugs in Medicare Part D

14 February 2025 - Most individuals in the US are concerned about prescription drug affordability. ...

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Bavarian Nordic receives US FDA approval of chikungunya vaccine for persons aged 12 and older

14 February 2025 - On track for commercial launch in the US in the first half of 2025. ...

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FDA approves Samsung Bioepis’ Ospomyv, Xbryk (denosumab-dssb), a biosimilar to Prolia and Xgeva

15 February 2025 - Samsung Bioepis’ first endocrinology biosimilar to be approved by the FDA – widening its therapeutic areas and ...

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Penmenvy, GSK’s 5 in 1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY

15 February 2025 - Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect ...

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FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes

14 February 2025 - Agency continues efforts to increase access to insulin treatment options. ...

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