FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Takeda receives US FDA approval of Fruzaqla (fruquintinib) for previously treated metastatic colorectal cancer

8 November 2023 - Fruzaqla is the first targeted therapy approved for metastatic colorectal cancer regardless of biomarker status or ...

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Paddy Gower has issues: blind, solo mum desperate for PHARMAC to fund life-changing medicine so she can see her kids

8 November 2023 - We sat in a field of wild daisies. Bright white and yellow against a backdrop of ...

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PHARMAC asked to reconsider funding RSV drug for at risk babies

9 November 2023 - Paediatricians and neonatal experts are pleading with PHARMAC to rethink its decision to stop funding a ...

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Updates to the HTA Policy and Methods Review Reference Committee (9 November 2023)

9 November 2023 - Two more documents are now available. ...

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First electronic product information published for selected human medicines

8 November 2023 - The Heads of Medicines Agencies (HMA), the European Commission and EMA have published for the first time ...

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Samsung Bioepis & Organon announce FDA acceptance of supplemental biologics license application for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira

7 November 2023 - Supplemental biologics license application based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: ...

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FDA approves new medication for chronic weight management

8 November 2023 - Today, the US FDA approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body ...

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Biogen-Sage Therapeutics post partum depression pill priced at $15,900

7 November 2023 - Sage Therapeutics has priced the oral post partum depression pill it developed with partner Biogen at ...

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Gilead Sciences Korea seeks reimbursement for Trodelvy

8 November 2023 - Gilead Sciences Korea is seeking insurance coverage of its new drug Trodelvy (sacituzumab govitecan) for the ...

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MHRA authorises enzyme inhibitor anastrozole to prevent breast cancer in post-menopausal women

6 November 2023 - Anastrozole is now authorised as a preventative treatment for post-menopausal women at moderate or high risk of ...

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PHARMAC publishes agenda for November 2023 PTAC meeting

8 November 2023 - Another underwhelming agenda; yet again there is no application for a cancer medicine. ...

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Zydus receives US FDA approval for Zituvimet to treat adult patients with type 2 diabetes mellitus

6 November 2023 - The company received final approval from the US FDA for its new drug application for Zituvimet ...

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PHARMAC proposing to fully fund testosterone gel for all who need it

8 November 2023 - PHARMAC is consulting on a proposal to fund testosterone gel without restrictions as an additional testosterone ...

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Janssen submits Phase 3 study data to the European Medicines Agency and US Food and Drug Administration for Sirturo (bedaquiline)

7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental ...

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Mitsubishi Tanabe Pharma Canada announces that Company's oral treatment formulation for amyotrophic lateral sclerosis has been added to the provincial drug plans in Prince Edward Island, Newfoundland and Labrador

7 November 2023 - Mitsubishi Tanabe Pharma Canada today announced that Radicava oral suspension (edaravone) is now covered under the Prince ...

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