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 treatment for wider range of patients with heart failure

24 February 2022 - Today, the U.S. FDA approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization ...

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EMA recommends approval of Spikevax for children aged 6 to 11

24 February 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use ...

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

24 February 2022 - To 20 February 2022, the TGA has received 451 reports which have been assessed as likely to ...

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Government of Canada signs new COVID-19 antibody therapy agreement

23 February 2022 - The Government of Canada is committed to protecting the health and safety of everyone in Canada ...

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ATAGI recommendations on the use of Spikevax (Moderna) COVID-19 vaccine in children aged 6 to 11 years

23 February 2022 - The Australian Technical Advisory Group on Immunisation (ATAGI) has made recommendations for the use of the Moderna ...

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FDA approves nalmefene hydrochloride 2 mg/2 mL injection for the treatment of known or suspected opioid overdose with natural or synthetic opioids

23 February 2022 - Purdue Pharma announced today that FDA has approved its abbreviated new drug application for nalmefene hydrochloride 2 ...

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FDA permits marketing of first condom specifically indicated for anal intercourse

23 February 2022 - Other FDA cleared condoms can continue to be used for contraception and to prevent sexually transmitted infections. ...

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Theragnostics announces US FDA approval for its radiodiagnostic imaging drug NephroScan (kit for the preparation of Technetium Tc 99m succimer injection)

23 February 2022 - NephroScan is now U.S. FDA approved for the preparation of Tc-99m DMSA. ...

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TGA checks need for another vax booster

23 February 2022 - Australia is looking at whether to offer a fourth COVID dose ahead of the flu season ...

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Annual report 2021: more Government assignments and increased EU cooperation on TLV

23 February 2022 - In 2021, the Swedish Dental and Pharmaceutical Benefits Agency, TLV, reported a number of urgent government assignments ...

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Medtronic receives FDA approval for InterStim X system, the next generation of the most personalised sacral nerve stimulation therapy for bladder and bowel control

22 December 2022 - New InterStim X system provides 10 to 15 years of battery life without the need to recharge. ...

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‘Grumpy’ TGA boss unloads over people downplaying COVID’s effect on kids

23 February 2022 - The head of Australia’s medicines regulator has unloaded on those downplaying the effect COVID-19 has on ...

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PHARMAC recommends funding cystic fibrosis medicine Trikafta but needs more funding

23 February 2022 - PHARMAC’s clinical experts are recommending cystic fibrosis drug Trikafta be funded for those aged over 12 ...

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MSAC Secretariat publishes agenda for June 2022 ESC meeting

23 February 2022 - The MSAC Secretariat has published a list of applications scheduled to be considered by the ESC ...

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PHARMAC’s clinical experts recommend funding Trikafta

23 February 2022 - PHARMAC today announces its clinical advisory committee PTAC has recommended funding cystic fibrosis treatment Trikafta with ...

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