regulatory approval

News

Roche gets EU okay for first HER2-low test kit

Roche has obtained a CE Mark in the EU for a companion diagnostic that can be used to identify patients with HER2-low metastatic breast cancer who may be eligible for trea

News

Enhertu gets FDA nod for tumour-agnostic HER2 cancers

The FDA has approved the use of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu for all HER2-positive solid tumours, in a first for both HER2 inhibitors a

News

Carvykti, Abecma move earlier in multiple myeloma treatment

Johnson & Johnson and Legend Biotech’s BCMA-targeted CAR-T therapy Carvykti has been approved by the FDA to treat patients with multiple myeloma after at least one pri

News

Basilea Pharmaceutica, ceftobiprole antibiotic

Basilea completes ceftobiprole marathon with FDA approval

Basilea Pharmaceutica will finally be able to bring its antibiotic ceftobiprole to the US market, around 15 years after the drug was first turned down by the FDA.

News

$Eko Health and ejection fraction$

FDA clears AI that detects heart failure using a stethoscope

The FDA has cleared an artificial intelligence algorithm that can detect signs of heart failure in seconds using a digital stethoscope during a standard physical exam.

News

FDA clears first DTx for depression from Otsuka, Click

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder.

Roche gets EU okay for first HER2-low test kit

Enhertu gets FDA nod for tumour-agnostic HER2 cancers

Carvykti, Abecma move earlier in multiple myeloma treatment

Basilea completes ceftobiprole marathon with FDA approval

FDA clears AI that detects heart failure using a stethoscope

FDA clears first DTx for depression from Otsuka, Click

Relief for AZ as Truqap hits the spot in prostate cancer

Coming soon: The Life Sciences Industry Report 2025 – insigh...

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