regulatory

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Close up of white pill with smiley face on a hand held by a young, ginger girl

HRA Pharma bids to bring first OTC contraceptive pill to US

Perrigo's HRA Pharma subsidiary has become the first drugmaker in the US to seek approval for an over-the-counter contraceptive pill.

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Eisai/Biogen could get FDA verdict on new Alzheimer's drug b...

The FDA has started an accelerated review of Eisai and Biogen's a new amyloid-targeting antibody lecanemab for Alzheimer's disease, with a 6 January deadline that keep them ahead of closest

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FDA rejection of Spero's tebipenem 'raises resistance threat...

The FDA's decision not to approve Spero Therapeutics' oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic re

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US panel backs Omicron-targeting vaccines for booster campai...

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA's Vaccines and Related Biological Produc

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Sarepta shares yo-yo as FDA places hold on Duchenne trial

Shares in Sarepta came under pressure after the biotech said it had temporarily halted a clinical trial of its new-generation Duchenne muscular dystrophy candidate, after a patient had a se

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FDA advisors back COVID jabs for very young children

The FDA's vaccines advisors have voted in favour of extending the use of mRNA-based COVID-19 vaccine from Moderna and Pfizer/BioNTech to include children from the ages of six months.

HRA Pharma bids to bring first OTC contraceptive pill to US

Eisai/Biogen could get FDA verdict on new Alzheimer's drug b...

FDA rejection of Spero's tebipenem 'raises resistance threat...

US panel backs Omicron-targeting vaccines for booster campai...

Sarepta shares yo-yo as FDA places hold on Duchenne trial

FDA advisors back COVID jabs for very young children

Ipsen' Bylvay fluffs its lines in biliary atresia trial

Discover a new era of healthcare panel engagement: Grounded ...

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