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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VenoStent technology receives breakthrough device designation by FDA

17 May 2022 - Designation to promote more rapid agency and market access for VenoStent. ...

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Understanding ‘evergreening’: making minor modifications of existing medications to extend protections

17 May 2022 - Recent studies have examined strategic behaviours in the pharmaceutical industry that extend patent and regulatory protection, known ...

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United Kingdom MHRA grants marketing authorisation for FYB201, Formycon's biosimilar for Lucentis

17 May 2022 - Formycon and its license partner Bioeq announce that today the MHRA has granted marketing authorisation in the ...

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MHRA approves faricimab through international work-sharing initiative

17 May 2022 - It is the first treatment approved by the UK regulator that has been made possible through the ...

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Ethical considerations for the inclusion of patient reported outcomes in clinical research

17 May 2022 - An international consensus Delphi process was developed according to the Enhancing the Quality and Transparency of Health ...

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FDA expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 years

17 May 2022 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine, authorising the use ...

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Dental AI start-up wins second FDA clearance to detect top oral diseases

16 May 2022 - The FDA has awarded dental AI start-up Overjet with landmark clearance to use its software to ...

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Health economic assessment of Xevudy for the treatment of COVID-19

17 May 2022 - TLV has produced a health economic assessment for the regions for the drug Xevudy (sotrovimab).  ...

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Ontario, British Columbia, Nova Scotia, New Brunswick, and Newfoundland, join a growing list of provinces providing public drug plan reimbursement for Teva Canada’s Ajovy (fremanezumab), for the preventive treatment of migraine in adults

17 May 2022 - Teva Canada welcomes the recently announced public formulary coverage for Ajovy (fremanezumab) by Ontario, British Columbia, ...

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Governor Hochul announces new watchdog bureau to tackle prescription drug costs

11 May 2022 - New pharmacy benefits bureau to supervise unregulated pharmacy benefit manager industry. ...

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Finerenone for treating chronic kidney disease in people with type 2 diabetes

17 May 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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International regulators and WHO: support health care professionals to enhance public confidence in COVID-19 vaccines

17 May 2022 - the EMA has endorsed a statement for health care professionals jointly developed by the International Coalition ...

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The drugs that give her life cost more than half the family's income

18 May 2022 - For Vickie Hudson-Craig,​ this year’s Budget could mean the difference between life and death. ...

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FDA authorises first COVID-19 test available without a prescription that also detects influenza and RSV

16 May 2022 - The EUA authorises at home sample collection with testing performed in a laboratory. ...

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MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment

17 May 2022 - Authorisation of the treatment is based on results from the Phase 3 trial. ...

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