Blue Shield of California slashes cost of world's best selling drug

1 October 2024 - Non-profit health plan collaborates with Fresenius Kabi and Evio Pharmacy Solutions to purchase FDA approved Humira biosimilar ...

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Highlights from the 9-12 December 2024 CHMP meeting

13 December 2024 - The EMA’s CHMP recommended seventeen medicines for approval at its December 2024 meeting.  ...

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Roche’s Vabysmo pre-filled syringe approved in the EU for three retinal conditions that can cause blindness

13 December 2024 - Vabysmo PFS is the first and only pre-filled syringe containing a bi-specific antibody, offering a convenient alternative ...

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FDA approves new treatment for congenital adrenal hyperplasia

13 December 2024 - Today, the US FDA approved Crenessity (crinecerfont) to be used together with glucocorticoids to control androgen levels ...

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Novartis and the pan-Canadian Pharmaceutical Alliance achieve milestone agreement for Pluvicto

13 December 2024 - Targeted radioligand therapy closer to public reimbursement for eligible Canadian patients with PSMA positive metastatic castration ...

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FDA accepts Ascendis Pharma’s supplemental biologics license application for TransCon hGH for the treatment of adults with growth hormone deficiency

12 December 2024 - PDUFA goal date is 27 July 2025. ...

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Roche Canada and the pan-Canadian Pharmaceutical Alliance successfully complete negotiations for Tecentriq SC (atezolizumab solution for subcutaneous injection)

13 December 2024 - Roche Canada today announced that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance for Tecentriq ...

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Deal struck to secure place of eczema drug on PBS

13 December 2024 - Health Minister Mark Butler has struck a deal to secure the place of a “life-changing” eczema ...

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Tolebrutinib designated breakthrough therapy by the FDA for non-relapsing secondary progressive multiple sclerosis

13 December 2024 - Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple ...

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FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma

13 December 2024 - Today, the FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, for ...

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Lilly's Omvoh (mirikizumab) recommended by CHMP for approval in the European Union for adults with moderately to severely active Crohn's disease

13 December 2024 - The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without ...

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UK MHRA grants innovation passport designation to ILiAD Biotechnologies BPZE1 next generation intranasal pertussis vaccine

4 December 2024 - ILiAD Biotechnologies today announced that the UK MHRA has granted Innovation Passport designation to BPZE1, the leading ...

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Hikma and Richter announce FDA submission acceptance for denosumab biosimilar products

12 December 2024 - Gedeon Richter and Hikma Pharmaceuticals today announced that the US FDA had accepted for review the ...

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CDER establishes new Center for Real World Evidence Innovation

12 December 2024 - Today, the US FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center ...

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Stoke Therapeutics receives FDA breakthrough therapy designation for zorevunersen for the treatment of Dravet syndrome

4 December 2024 - Supported by evidence from clinical studies that indicate that zorevunersen may demonstrate substantial improvement over available therapies. ...

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Phanes Therapeutics’ PT217 granted fast track designation by the FDA for NEPC

4 December 2024 - This is the second fast track designation granted to PT217 by the agency ...

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