HanchorBio scores first FDA orphan drug tag for gastric cancer therapy

The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients

Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough

If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US

Clinigen bags Japan's nod to human milk-based medicine for preterm infants

PreemieFort Enteral Solution's approval marks the first time a nutritional product derived from human milk has been recognized as a prescription medicine anywhere in the world

Lyell Immunopharma launches groundbreaking Phase 3 CAR T-Cell trial for aggressive lymphoma

PiNACLE is a head-to-head study comparing its next-generation CAR T-cell therapy against established therapies liso-cel and axi-cel in patients with relapsed or refractory large B-cell lymphoma

Centivax launches first human trial of universal flu vaccine

NATCO receives CDSCO approval for Semaglutide in India

Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus

Zydus receives final approval from USFDA for Ammonium Lactate Cream, 12%

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”

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

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

Merck KGaA’s Belen Garijo to become CEO of Sanofi

Garijo will be the first woman to lead Sanofi in its history