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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The sickest patients are fleeing private Medicare plans costing taxpayers billions

11 November 2024 - Medicare Advantage patients in the last year of life were far more likely to switch to traditional ...

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Alectinib hydrochloride for the adjuvant treatment of patients with ALK positive non-small-cell lung cancer

13 November 2024 - NICE has published final evidence-based recommendations on the use of alectinib hydrochloride for the adjuvant treatment ...

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Ojjaara (momelotinib) approved in Canada for the treatment of myelofibrosis in adults who have moderate to severe anaemia

12 November 2024 - Ojjaara (momelotinib) is the only approved treatment for newly diagnosed and previously treated myelofibrosis patients who have ...

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Abeona Therapeutics announces FDA acceptance of BLA resubmission of prademagene zamikeracel for the treatment of recessive dystrophic epidermolysis bullosa

12 November 2024 -  Abeona Therapeutics today announced that the US FDA has accepted for review Abeona’s resubmission of its ...

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Genascence granted FDA fast track designation for GNSC-001 in patients with osteoarthritis of the knee

12 November 2024 - GNSC-001 is designed to offer long-term, sustained inhibition of IL-1 following a single injection into the affected ...

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Intercept receives complete response letter from FDA addressing Ocaliva supplemental new drug application

13 November 2024 - Intercept Pharmaceuticals today announced that the US FDA has issued a complete response letter that addresses ...

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Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR mutated non-small cell lung cancer

12 November 2024 - Daiichi Sankyo and AstraZeneca’s new application is based on the TROPION-Lung05 Phase 2 trial and supported ...

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New heart medicine for 18,000 New Zealanders

12 November 2024 - PHARMAC has decided to fund the medicine empagliflozin for thousands of people with a type of ...

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Unicycive Therapeutics announces US FDA acceptance of the new drug application for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis

11 November 2024 - FDA sets PDUFA action date of 28 June 2025. ...

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Neurotech provides update on BLA for NT-501 as a treatment for macular telangiectasia type 2

8 November 2024 - Neurotech Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date by three months ...

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November 2024 decisions

11 November 2024 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...

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Nipocalimab is the first and only investigational therapy granted US FDA breakthrough therapy designation for the treatment of adults living with moderate to severe Sjögren’s disease

11 November 2024 - The breakthrough therapy designation for investigational nipocalimab in Sjögren’s disease, a prevalent autoantibody disease with no approved ...

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MHRA grants marketing authorisation for Balversa (erdafitinib) as monotherapy for the treatment of adults with unresectable or metastatic urothelial carcinoma (UC) harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting

6 November 2024 - Erdafitinib is the first and only bladder cancer therapy that targets FGFR3 alterations and has been ...

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PHARMAC funds new medicine and removes renewal criteria for ADHD and narcolepsy treatments

11 November 2024 - PHARMAC will make two changes for people with attention deficit hyperactivity disorder (ADHD) and narcolepsy this ...

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World leading approach to protect babies from RSV

10 November 2024 - Australian mums and their newborn babies will have free access to the best and most comprehensive ...

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