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Results For "FDA-approval"

438 News Found

Agilent’s PD-L1 test gains FDA nod for ovarian cancer
News | February 16, 2026

Agilent’s PD-L1 test gains FDA nod for ovarian cancer

This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA


FDA nod to Acrotech's new eczema treatment
Drug Approval | February 14, 2026

FDA nod to Acrotech's new eczema treatment

ADQUEY’s approval opens the door to a new alternative for millions of Americans struggling with atopic dermatitis


Citius Oncology expands LYMPHIR access across Europe via exclusive Uniphar deal
Supply Chain | February 14, 2026

Citius Oncology expands LYMPHIR access across Europe via exclusive Uniphar deal

Under the deal, Uniphar will serve as LYMPHIR’s exclusive distribution partner across designated Western and Eastern European territories


Merck’s KEYTRUDA bags FDA nod for platinum-resistant ovarian cancer
News | February 13, 2026

Merck’s KEYTRUDA bags FDA nod for platinum-resistant ovarian cancer

KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components


Zydus receives USFDA ODD for Desidustat for the treatment of sickle cell disease
Drug Approval | February 07, 2026

Zydus receives USFDA ODD for Desidustat for the treatment of sickle cell disease

This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease


Hologic’s Aptima HPV test bags FDA nod for primary cervical cancer screening
News | February 07, 2026

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


AGC Biologics powers commercial launch of its life-changing gene therapy for rare childhood immune disorder
Biotech | January 20, 2026

AGC Biologics powers commercial launch of its life-changing gene therapy for rare childhood immune disorder

Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector


Teva’s AJOVY gains spotlight as first preventive migraine treatment for kids
R&D | January 15, 2026

Teva’s AJOVY gains spotlight as first preventive migraine treatment for kids

The findings, from the SPACE study, paved the way for FDA approval of AJOVY for pediatric patients aged 6-17 years weighing 45 kilograms