Recommendations made by the PBAC – December 2025 intracycle meeting

30 January 2026 - The recommendations from the December 2025 PBAC intracycle meeting are now available.  ...

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Highlights from the 26-29 January 2026 CHMP meeting

30 January 2026 - The EMA’s CHMP recommended six medicines for approval at its January 2026 meeting. ...

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Canadians wait too long for access to innovative drugs, cautions the MEI

29 January 2026 - Pharmaceutical innovation is responsible for up to 66% of the increase in the age of death ...

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Celltrion secures Canadian approval for Omlyclo 300 mg PFS and auto-injector formulations

29 January 2026 - Celltrion said Thursday that it has received additional approval from Health Canada for its chronic idiopathic ...

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Government of Canada announces the new Chairperson of the Patented Medicine Prices Review Board

29 January 2026 - Today, the Honourable Marjorie Michel, Minister of Health, announced the designation of a new Chairperson for ...

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QTX-2101 awarded FDA fast track designation for the treatment of acute promyelocytic leukaemia

29 January 2026 - Quetzal Therapeutics announced that the US FDA has granted fast track designation to QTX-2101, the company’s ...

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‘Transformative’ HIV PrEP shot slowly overcomes cost hurdles

28 January 2026 - HIV/AIDS activists heralded the approval of a new twice-yearly pre-exposure prophylaxis (PrEP) medication last year, but ...

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CMS announces selection of drugs for third cycle of Medicare drug price negotiation program, including first ever Part B drugs

27 January 2026 - The Centers for Medicare & Medicaid Services announced the selection of 15 high cost prescription drugs covered ...

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Summit Therapeutics announces US FDA acceptance of biologics license application seeking approval for ivonescimab in combination with chemotherapy in treatment of patients with EGFRm NSCLC post-TKI therapy

29 January 2026 - Summit Therapeutics today announced that the US FDA has accepted for filing Summit's biologics license application seeking ...

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Tenpoint Therapeutics announces FDA approval of Yuvezzi, the first and only combination eye drop approved to treat presbyopia

28 January 2026 - Tenpoint Therapeutics today announced that the US FDA approved Yuvezza (carbachol and brimonidine tartrate ophthalmic solution) ...

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Dong-A ST receives Health Canada approval for Stelara biosimilar Imuldosa

28 January 2026 - Dong-A ST announced on Wednesday that Health Canada has granted marketing authorisation for Imuldosa (ingredient: ustekinumab), ...

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Cipher Pharmaceuticals announces Health Canada's acceptance for review of new drug submission for Natroba (spinosad)

28 January 2026 - Cipher Pharmaceuticals today announced that Health Canada has accepted for review Cipher's new drug submission for ...

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Elevar Therapeutics submits new drug application to FDA for lirafugratinib as second-line treatment option for cholangiocarcinoma

28 January 2026 - Elevar Therapeutics today announced it submitted a new drug application to the US FDA for its investigational ...

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Immix Biopharma receives US FDA breakthrough therapy designation for NXC-201

28 January 2026 - Breakthrough therapy designation granted to NXC-201 based on positive NEXICART-2 Phase 2 interim clinical results, presented at ...

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Biogen’s litifilimab receives FDA breakthrough therapy designation for cutaneous lupus erythematosus, a disease with no targeted treatment options

28 January 2026 - Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result ...

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