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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FDA approves first targeted therapy for HER2 low breast cancer

5 August 2022 - Today, the U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an intravenous infusion for the treatment of ...

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Calquence tablet formulation approved in the US across current indications

5 August 2022 - New formulation can be co-administered with gastric acid-reducing agents. ...

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Acadia Pharmaceuticals receives complete response letter from U.S. FDA for supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis

4 August 2022 - Acadia Pharmaceuticals today announced that the company has received a complete response letter from the U.S. ...

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Australia secures new third generation monkeypox virus vaccine

4 August 2022 - The Albanese Government has secured 450,000 doses of the new third generation monkeypox virus vaccine by Bavarian ...

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U.S. regulators defend requiring more data on monkeypox drug

4 August 2022 - As U.S. monkeypox cases rise, U.S. health agencies in a medical journal article published on Wednesday ...

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The patient voice – the value of patient-reported outcomes in HTA

4 August 2022 - The patient’s voice is increasingly important in securing access for therapies in markets and demonstrating how ...

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Advanced oesophageal carcinoma: nivolumab in combination with chemotherapy or ipilimumab prolongs life compared to chemotherapy alone

1 August 2022 - The additional clinical benefit cannot be quantified because the data on health status and health-related quality ...

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Regression models for ordinal outcomes

4 August 2022 - Ordinal logistic regression models are tailored for the analysis of ordinal outcomes. ...

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Vaxcyte provides positive regulatory updates for VAX-24 adult and paediatric programs

4 August 2022 - Company receives FDA fast track designation for VAX-24 in adults. ...

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Bulk billing ‘on verge of collapse’

5 August 2022 - Doctors have warned that the ­nation is facing the “collapse of bulk billing” in general practice, ...

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ICER publishes evidence report on treatments for amyotrophic lateral sclerosis

4 August 2022 - Given current data, AMX0035 is comparable or better to standard of care; AMX0035 would achieve common thresholds ...

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U.S. prescription drug pricing doesn’t favour the patient: case of sub-optimal market for cancer pharmaceuticals

3 August 2022 - The high costs of cancer drugs impact patients negatively. In fact, the out of pocket cost ...

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Panicked patients as popular medications get wiped from pharmacy shelves

4 August 2022 - Widely used medications — including one used to treat ADHD — are missing from Australian shelves amid ...

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Lynparza approved in the EU as adjuvant treatment for patients with germline BRCA mutated HER2 negative high-risk early breast cancer

4 August 2022 - First and only approved medicine targeting BRCA mutations in early breast cancer ...

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Travere Therapeutics provides regulatory updates on its development programs

3 August 2022 - Pegtibatinase granted breakthrough therapy designation by FDA. ...

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