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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Leaked TRIPS proposal misguided about improving global COVID-19 vaccination rates

24 March 2022 - The leaked proposal on the waiver on intellectual property rights for COVID-19 vaccines is misguided and ...

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Pressured by patients, FDA reviews ALS drug with modest data

25 March 2022 - The FDA meets next week to review a closely watched drug for ALS, or Lou Gehrig’s ...

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Priorities for NICE in health and social care

23 March 2022 - Over the past two years there has been an unprecedented increase in medical research, the NHS has ...

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Despite competition, U.S. cancer drug prices rose even as they fell in Germany and Switzerland

24 March 2022 - Even as prices rose substantially in the U.S. over a recent 12 year period, a new ...

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Abbott's FreeStyle Libre is first and only CGM system to gain expanded reimbursement in Japan to include all people with diabetes who use insulin

24 March 2022 - Without expanded coverage, continuous glucose monitoring reimbursements are limited to segment of people with diabetes who require ...

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Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis of COVID-19

24 March 2022 - Recommendation based on Phase 3 PROVENT trial showing a significant reduction in the risk of developing ...

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Nivolumab with ipilimumab for untreated advanced renal cell carcinoma

24 March 2022 - NICE has published evidence-based recommendations on nivolumab (Opdivo) with ipilimumab (Yervoy) for untreated advanced renal cell ...

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Fresenius Kabi announces FDA approval of SMOFlipid lipid injectable emulsion for paediatric patients requiring parenteral nutrition

24 March 2022 - First and only four-oil lipid injectable emulsion indicated for paediatric parenteral nutrition, including term and preterm neonates. ...

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U.S. FDA approves streamlined process for initiating HIV therapy with Cabenuva (cabotegravir and rilpivirine), the first and only complete long-acting injectable HIV treatment

24 March 2022 - Adults living with HIV now have an option to start injectable regimen without the need for ...

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Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus vaccine candidate for the prevention of RSV in older adults

24 March 2022 - Pfizer today announced that its respiratory syncytial virus vaccine candidate, PF-06928316 or RSVpreF, received breakthrough therapy ...

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Fennec Pharmaceuticals resubmits new drug application to the U.S. FDA for Pedmark

24 March 2022 - Fennec Pharmaceuticals today announced the resubmission of its new drug application to the U.S. FDA for ...

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Lilly announces complete response letter for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with non-squamous non-small cell lung cancer

24 March 2022 - Eli Lilly today announced that the U.S. FDA has issued a complete response letter (CRL) for ...

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Moderna finalises strategic partnership with Australian Government

23 March 2022 - On-shore manufacturing facility based in Melbourne, Australia, expected to produce up to 100 million mRNA respiratory ...

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TGA approves new medicine for patients with multiple sclerosis

24 March 2022 - Ponesimod is a sphingosine 1 phosphate receptor 1 modulator. ...

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COVID-19 vaccine weekly safety report (24 March 2022)

24 March 2022 - To 20 March 2022, the TGA has received 485 reports which have been assessed as likely to ...

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