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Clinigen bags Japan's nod to human milk-based medicine for preterm infants
R&D | February 16, 2026

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


Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough
Drug Approval | February 16, 2026

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


STADA & Bio-Thera bag European nod for Gotenfia
Drug Approval | February 16, 2026

STADA & Bio-Thera bag European nod for Gotenfia


Amgen scores EU nod for UPLIZNA in rare autoimmune disease
News | February 16, 2026

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


Lundbeck’s bocunebart shows breakthrough potential in migraine prevention
Clinical Trials | February 16, 2026

Lundbeck’s bocunebart shows breakthrough potential in migraine prevention

Bocunebart works by blocking pituitary adenylate cyclase-activating polypeptide


BridgeBio reports breakthrough results in Phase 3 achondroplasia trial
Biopharma | February 16, 2026

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
Clinical Trials | February 16, 2026

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


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