FDA calls for black box warning to be removed from HRT products
The US Food and Drug Administration (FDA) is working with manufacturers to remove black box warnings across hormone replacement therapy (HRT)…
Women's Health
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Health Canada grants NOC for AstraZeneca’s breast cancer therapy
Health Canada has issued a notice of compliance (NOC) for AstraZeneca’shuman epidermal growth factor receptor 2 (HER2)-directed antibody drug conjugate…
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EMD Serono partners US government to widen IVF access
Merck’s healthcare division in Canada and the US, EMD Serono, has signed an agreement with the Trump administration to expand…
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FDA approves mifepristone generic as political abortion war rages on
The US Food and Drug Administration (FDA) has approved Evita Solutions’ generic form of mifepristone, one of the two medications…
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Biogen’s Zurzuvae approved as first postpartum depression drug in Europe
Millions of parents in Europe who suffer from postpartum depression will now have access to a pharmaceutical treatment, following the…
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Health Canada approves AbbVie’s Elahere for ovarian cancer
Health Canada has approved AbbVie's antibody-drug conjugate (ADC), Elahere (mirvetuximab soravtansine for injection), to treat adults with certain types of…
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MHRA approves GSK’s oral antibiotic for UTIs in females
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to GSK's oral antibiotic pill, Blujepa (gepotidacin), for…
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Daiichi Sankyo and AstraZeneca’s Datroway receives approval in China
Daiichi Sankyo and AstraZeneca have received approval from China’s National Medical Products Administration (NMPA) for Datroway (datopotamab deruxtecan) to treat…
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Gates Foundation invests $2.5bn in women’s health-focused R&D
The Gates Foundation has announced an investment of $2.5bn through to 2030, dedicated to expediting research and development (R&D) with…
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Novartis’ ribociclib approved in Canada for early breast cancer
Health Canada has granted a notice of compliance for Novartis Canada’s Kisqali (ribociclib tablets) plus an aromatase inhibitor for the…
