regulatory

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Mosquito is extracting blood from skin and has turned bright red

Takeda dengue vaccine receives positive CHMP opinion

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Takeda GmbH’s live, attenuated dengue tetravalent vaccine, Qdenga

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US clears Omicron shots from Pfizer, Moderna for children

The US authorities have authorised use of two bivalent COVID-19 booster vaccines from Pfizer/BioNTech and Moderna – targeting the BA.4 and BA.5 subvariants of Omicron – for use in children

Views & Analysis

The criticality of compliance

Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory.

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Why research into the mental health impact of a rare disease diagnosis is long overdue

Wellcome funds work on regulating digital mental health tool...

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy?

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Better Therapeutics files for FDA approval of diabetes DTx

Digital health company Better Therapeutics has submitted its lead prescription digital therapeutic (DTx) BT-001 to the FDA, seeking approval for use by adults with type 2 diabetes (T2D).

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Helping to support momentum on antimicrobial innovation

Undeterred by FDA setback, GSK snaps up Spero antibiotic

GSK is paying $66 million upfront to license rights to Spero Therapeutics novel antibiotic tebipenem Hbr, unswayed by the FDA's decision earlier this year not to approve the drug for adults

Takeda dengue vaccine receives positive CHMP opinion

US clears Omicron shots from Pfizer, Moderna for children

The criticality of compliance

Wellcome funds work on regulating digital mental health tool...

Better Therapeutics files for FDA approval of diabetes DTx

Undeterred by FDA setback, GSK snaps up Spero antibiotic

Biotech is back, with Craig Ackerman

Using AI-driven synthetic personas to take your insights fur...

regulatory

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