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

Dewpoint Therapeutics selects groundbreaking MYC development candidate

MYC, a master regulator of oncogenic transcription, drives multiple high-burden cancers but has long eluded direct pharmacologic control

STADA & Bio-Thera bag European nod for Gotenfia

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

Amgen scores EU nod for UPLIZNA in rare autoimmune disease

The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses

BridgeBio reports breakthrough results in Phase 3 achondroplasia trial

Achondroplasia is a genetic condition driven by FGFR3 that affects more than stature alone

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

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

Precision BioSciences cleared by FDA to launch groundbreaking Duchenne gene editing trial

PBGENE-DMD is designed to permanently correct mutations in the dystrophin gene between exons 45 and 55, the “hot-spot” region affecting roughly 60% of DMD patients