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Roche appoints Mark Dawson as new Head of Pharma Research and Early Development
People | February 17, 2026

Roche appoints Mark Dawson as new Head of Pharma Research and Early Development

Dawson joins Roche from the Peter MacCallum Cancer Centre, where he serves as Associate Director of Research


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


Dewpoint Therapeutics selects groundbreaking MYC development candidate
R&D | February 16, 2026

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
Drug Approval | February 16, 2026

STADA & Bio-Thera bag European nod for Gotenfia


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


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


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