Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) as first-line treatment for patients with advanced renal cell carcinoma

14 April 2021 - Approval based on Phase 3 CheckMate-9ER trial results showing Opdivo in combination with Cabometyx significantly improved overall ...

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Public consultation – draft 2021-22 Cost Recovery Implementation Statement for listing medicines on the PBS and designated vaccines on the NIP

15 April 2021 - Consultation on the content of the draft Cost Recovery Implementation Statement for listing medicines on the ...

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Petition filed for better access to haemophilia A drug

14 April 2021 - Parents of paediatric patients with haemophilia A are demanding the regulator to change the criteria for ...

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Moleculin awarded new rare paediatric disease designation from U.S. FDA for WP1066 for the treatment of ependymoma

14 April 2021 - Moleculin Biotech announced today that the U.S. FDA has granted rare paediatric disease designation to its ...

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TGA grants provisional determination to GSK for COVID-19 monoclonal antibody treatment - sotrovimab

14 April 2021 - The TGA has granted a provisional determination to GSK in relation to the monoclonal antibody treatment, ...

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Tagrisso approved in China in early lung cancer

14 April 2021 - Approval based on unprecedented results from the ADAURA Phase III trial where Tagrisso reduced the risk ...

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Easier access to rare metabolic disorder treatments

14 April 2021 - PHARMAC is making it easier for clinicians to access six treatments for rare metabolic disorders for ...

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Atossa Therapeutics announces ovarian cancer patient has begun treatment with oral endoxifen under FDA’s Expanded Access Pathway

13 April 2021 - Atossa Therapeutics today announced that an ovarian cancer patient has begun treatment with Atossa’s proprietary oral endoxifen.  ...

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New recommendations on the critical appraisal of systematic reviews with cost and cost effectiveness outcomes

13 April 2021 - ISPOR announced today the publication of new guidance on how to evaluate the quality and risk ...

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Scotland opens door to Translarna for Duchenne muscular dystrophy

13 April 2021 - A disparity in UK access to a medicine for Duchenne muscular dystrophy has been addressed, after ...

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Qilian International announces inclusion of 16 products into China's National Reimbursement Drugs List

13 April 2021 - Qilian International today announced that 16 of its products have been included in the latest version of ...

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Europe tries to lower drug prices with small doses of transparency

13 April 2021 - For countries in Europe, negotiating a deal with a pharma company over drug prices is the ...

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Four medicines accepted for use by NHS Scotland

13 April 2021 - The Scottish Medicines Consortium has approved NHS funding for four new medicines, including treatments for multiple ...

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FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer

13 April 2021 - Today the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics) for patients ...

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vTv Therapeutics receives FDA breakthrough therapy designation for TTP399 for the treatment of type 1 diabetes

13 April 2021 - Designation offers potential for expedited development pathway and reinforces TTP399’s potential to provide a substantial clinical benefit. ...

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