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 grants breakthrough therapy designation for Dizal Pharmaceutical's DZD9008 in patients with locally advanced or metastatic non-small cell lung cancer harbouring EGFR Exon 20 insertion

27 January 2022 - Breakthrough therapy designation further demonstrates excellent clinical profile of DZD9008 (sunvozertinib). ...

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TGA approves Tepmetko for patients with non-small-cell lung cancer

27 January 2022 - Tepotinib (Tepmetko) has provisional approval in Australia for the treatment of adult patients with locally advanced or ...

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The price of cystic fibrosis drugs is still too high

27 January 2022 - The Swedish Dental and Pharmaceutical Benefits Agency, TLV, has decided that Kaftrio and Kalydeco for cystic fibrosis ...

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COVID-19: EMA recommends conditional marketing authorisation for Paxlovid

27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...

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Lantern Pharma receives rare paediatric disease and orphan drug designations for LP-184 for the treatment of atypical teratoid rhabdoid tumour

24 January 2022 - Lantern Pharma today announced that the U.S. FDA has granted both rare paediatric disease designation and orphan ...

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COVID-19 vaccine weekly safety report (27 January 2022)

27 January 2022 - To 23 January 2022, the TGA has received 431 reports which have been assessed as likely to ...

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Do federal price transparency regulations neglect oncology patients?

24 January 2022 - The National Cancer Institute has identified measuring, understanding, and addressing cancer-related patient financial hardship as a top ...

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2022 April price disclosure cycle – indicative prices

27 January 2022 - Indicative 1 April 2022 prices resulting from the 2022 April Cycle of Price Disclosure have now been ...

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Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA

27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...

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Immunocore announces FDA approval of Kimmtrak (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma

26 January 2022 - Kimmtrak is the first T cell receptor therapeutic to receive regulatory approval. ...

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Former bowel cancer patient calls for NZ to fund drug she says saved her life

26 January 2022 - A woman with bowel cancer who was told she may have two years to live says ...

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PHARMAC confirms access criteria for COVID-19 treatments

26 January 2022 - PHARMAC has today confirmed the access criteria for two COVID-19 treatments – baricitinib and casirivimab with ...

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Catalyst Biosciences receives rare paediatric disease designation for CB 4332 for the treatment of CFI deficiency

25 January 2022 - Catalyst Biosciences today announced the U.S. FDA has granted rare paediatric disease designation for CB 4332 for ...

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Incyte provides update on parsaclisib and MCLA-145

25 January 2022 - Incyte today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of ...

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SNIPR BIOME announces US FDA grants fast track designation for SNIPR001 for prevention of bloodstream infections in haematologic cancer patients

25 January 2022 - SNIPR Biome has been granted fast track designation by the US FDA for SNIPR001.  ...

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