Hologic’s Aptima HPV test bags FDA nod for primary cervical cancer screening
Hologic has been at the forefront of cervical cancer screening for decades
Hologic has been at the forefront of cervical cancer screening for decades
Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
The facility is dedicated to breakthrough innovations in laboratory instruments that detect infectious diseases, cancer, and blood disorders
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration
TB Alliance will continue to lead clinical development, while Lupin will leverage its global manufacturing, regulatory, and supply chain expertise to ensure the drug reaches patients worldwide
Over a two-decade career, Dr. Berman has worked on more than a dozen clinical-stage immunotherapies, including senior leadership roles in developing four oncology biologics
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