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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EMA recommends suspension of sickle cell disease medicine Oxbryta

26 September 2024 - The EMA’s CHMP has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta ...

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Pfizer voluntarily withdraws all lots of sickle cell disease treatment Oxbryta (voxelotor) from worldwide markets

25 September 2024 - Pfizer announced today that it is voluntarily withdrawing all lots of Oxbryta (voxelotor) for the treatment of ...

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Tepezza (teprotumumab) receives approval in Japan for the treatment of active thyroid eye disease

24 September 2024 - Amgen today announced Tepezza (teprotumumab) has been approved for the treatment of active or high clinical activity ...

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Health Canada grants marketing authorisation of first CRISPR/Cas9 gene edited therapy, Casgevy (exagamglogene autotemcel), for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia

25 September 2024 - First regulatory authorisation of a CRISPR-based gene-editing therapy in Canada. ...

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Pfizer Canada and BioNTech receive Health Canada approval of Omicron KP.2 variant adapted COVID-19 vaccine

24 September 2024 - Omicron KP.2 variant adapted vaccine Comirnaty is now authorised in Canada for individuals 6 months of age ...

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Moderna receives Health Canada approval for updated COVID-19 vaccine targeting KP.2 variant of SARS-COV-2 for ages six months and older

17 September 2024 - Spikevax is the first updated COVID-19 vaccine authorised in Canada for 2024-2025, offering a timely solution to ...

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FDA approves new drug to treat Niemann-Pick disease, type C

24 September 2024 - Today, the US FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease ...

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FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy

25 September 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage ...

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Trifluridine with tipiracil hydrochloride in combination with bevacizumab for the treatment of patients with metastatic colorectal cancer after two systemic treatments (final guidance)

25 September 2024 - NICE has published final evidence-based recommendations on the use of trifluridine with tipiracil hydrochloride (Lonsurf) for ...

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PhRMA scores a small win in legal challenge to Medicare’s drug price negotiation

20 September 2024 - An appeals court revived the case and sent it back to a lower court in Texas. ...

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GSK’s Menveo meningococcal vaccine in new single-vial, fully liquid presentation receives positive European CHMP opinion

24 September 2024 - Marketing authorisation in EU expected by November 2024. ...

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Santhera announces acceptance by Swissmedic of marketing authorisation application for Agamree (vamorolone) in Duchenne muscular dystrophy

24 September 2024 - Santhera Pharmaceuticals announces that Swissmedic, the Swiss Agency for Therapeutic Products, has accepted for review the ...

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Lilly's Kisunla (donanemab-azbt) approved in Japan for the treatment of early symptomatic Alzheimer's disease

24 September 2024 - Japan is the second major market where Kisunla has received approval. ...

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Takeda receives approval for Fruzaqla (fruquintinib) in Japan for the treatment of unresectable advanced or recurrent colorectal cancer

24 September 2024 - Approval based on results from positive, global, Phase 3 FRESCO-2 trial. ...

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FDA accepts Arcutis’ supplemental new drug application for Zoryve (roflumilast) foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over

24 September 2024 - US FDA has set a PDUFA target action date of 22 May 2025. ...

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