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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Grifols’ Biotest receives FDA approval for innovative Yimmugo immunoglobulin to treat primary immunodeficiencies

17 June 2024 - Launching Yimmugo in the US will over time significantly add to Grifols Group sales and underpins ...

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PHARMAC improves access to breast cancer treatments

18 June 2024 - PHARMAC has changed the criteria for two breast cancer medicines which means people with a particular ...

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US FDA rare paediatric disease designation granted to RC220 bisantrene for the treatment of paediatric AML

18 June 2024 - Race Oncology is pleased to announce that the US FDA has extended rare paediatric disease designation ...

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Subcutaneous amivantamab biologics license application submitted to US FDA for patients with EGFR mutated non-small-cell lung cancer

17 June 2024 - Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five minute administration ...

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US FDA approves Capvaxive (pneumococcal 21 valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults

17 June 2024 - Capvaxive (V116) is specifically designed for adults and covers serotypes responsible for approximately 84% of invasive pneumococcal ...

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Awiqli - world's first once-weekly basal insulin - now available in Canada

17 June 2024 - Novo Nordisk is pleased to announce Canada will be the first country worldwide to launch Awiqli (insulin ...

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Bavarian Nordic completes BLA submission to US FDA for its Chikungunya vaccine candidate

17 June 2024 - First regulatory submission completed for CHIKV VLP seeking approval of the vaccine candidate for immunisation against chikungunya ...

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FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma

17 June 2024 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for ...

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First new Alzheimer’s drugs in 20 years to bring hope for early stage patients

16 June 2024 - Two new Alzheimer’s drugs aimed at slowing cognitive delay and heralded as a step towards prevention ...

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Extremely rare disease drug Ceprotin clears major hurdle to reimbursement

14 June 2024 - Ceprotin (protein C concentrate), an ultra-rare disease treatment developed by Takeda Pharmaceutical Korea, has passed the ...

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Blue Cross Blue Shield of Michigan dropping coverage of weight loss drugs

14 June 2024 - Michigan's largest insurance company said it will begin eliminating coverage of various weight loss drugs next ...

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Novavax submits application to US FDA for updated protein based 2024-2025 formula COVID-19 vaccine

14 June 2024 - Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3. ...

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FDA approves blinatumomab as consolidation for CD19 positive Philadelphia chromosome negative B-cell precursor acute lymphoblastic leukaemia

14 June 2024 - Today, the FDA approved blinatumomab (Blincyto, Amgen) for adult and paediatric patients one month and older ...

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FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer

14 June 2024 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with carboplatin plus paclitaxel followed by single-agent durvalumab for ...

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FDA approves Adbry (tralokinumab-ldrm) auto-injector for the treatment of adults with moderate to severe atopic dermatitis

13 June 2024 - Single-dose auto-injector will provide adult patients in the US with an alternative method of administration for Adbry, ...

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