FDA

News

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

News

GSK's daprodustat will have to face FDA advisory committee

GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug

News

Xenpozyme is first FDA-approved drug for rare disease ASMD

Sanofi now has approval on both sides of the Atlantic for Xenpozyme – its enzyme replacement therapy for rare disease acid sphingomyelinase deficiency (ASMD) – after getting a green light f

R&D

Automation in the clinical laboratory. Pipetting robot laboratory. Medicine robotics. Research and science background

Expectations rise for gene therapy to change treatment lands...

After a recent approval, there are now three gene therapies available on the US market.

Digital

Health Innovators – Amy Abernethy and Jennifer Goldsack Part...

Verily’s Amy Abernethy and DiMe’s Jennifer Goldsack return for a second conversation on data and healthcare, this one focusing on specific use cases and examples.

Patients