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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Withdrawals from pharmaceutical benefits on 1 October 2021

8 September 2021 - Suboxone is among the medicines that will be withdrawn from the drug benefits at the companies' ...

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Nivolumab scores a rare 'no' from NICE

8 September 2021 - Nivolumab scores only its second final rejection to date from NICE. ...

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Ultragenyx Canada announces Health Canada approval of a second indication for Crysvita (burosumab injection) for the treatment of tumour induced osteomalacia in adults

7 September 2021 - Ultragenyx Pharmaceutical today announced that Crysvita (burosumab Injection) has been approved by Health Canada for the treatment ...

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Intelivation Technologies received FDA approval for the Advantage-C PEEK cervical interbody fusion device

8 September 2021 - Intelivation Technologies announced today that they have achieved FDA 510(k) Clearance of the Advantage-C PEEK cervical ...

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Phathom Pharmaceuticals submits two NDAs to U.S. FDA for vonoprazan-based treatment regimens for the treatment of H. pylori infection

8 September 2021 - Phathom Pharmaceuticals announced today that it has submitted two new drug applications to the U.S. FDA for ...

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FDA grants Madorra breakthrough device designation status for treatment of moderate to severe vulvovaginal atrophy

8 September 2021 - Clinical trials of Madorra therapy system show promising results for treatment of vulvovaginal atrophy. ...

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HiberCell receives fast track designation from FDA for first in human studies of PERK inhibitor (PERKi) HC-5404-FU

8 September 2021 - C-5404-FU PERKi program is currently in a Phase 1a clinical trial for the treatment of solid ...

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Congress is ready to dig into drug prices

7 September 2021 - After months of drama and procedural votes, Congress is about to dive into the legislative process on ...

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NICE draft guidance recommends apalutamide for treating prostate cancer

8 September 2021 - NICE has today published final draft guidance which now recommends apalutamide (Erleada; Janssen) plus androgen deprivation therapy ...

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TGA approves new cancer medicine

7 September 2021 - Luspatercept (Reblozyl) is used to treat patients with certain transfusion-dependent anaemias. ...

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Singapore's health care system: key features, challenges, and shifts

2 September 2021 - Since Singapore became an independent nation in 1965, the development of its health care system has been ...

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U.S. FDA accepts for priority review supplemental new drug application for Oxbryta (voxelotor) for the treatment of sickle cell disease in children ages 4 to 11

7 September 2021 - New drug application for Oxbryta dispersible tablets also accepted for priority review. ...

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Reimbursement uncertain for Piqray targeting PIK3CA mutation in breast cancer

7 September 2021 - The first and only targeted therapy to treat hormone receptor positive and human epidermal growth factor ...

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To lower drug costs, define ‘cost’ to mean net cost after rebates

7 September 2021 - In what could be a turning point in the prescription drug debate, President Biden has made ...

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Landmark new medicines agreements to bring significant benefits for Australian patients

7 September 2021 - Australians will have more affordable, improved and guaranteed access to medicines under landmark long-term strategic agreements between ...

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