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3326 News Found

FDA accepts Deciphera’s NDA for tirabrutinib in rare aggressive brain lymphoma
Drug Approval | February 18, 2026

FDA accepts Deciphera’s NDA for tirabrutinib in rare aggressive brain lymphoma

The drug targets relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma


Newron Pharmaceuticals bags up to €38 million to fuel Phase III ENIGMA-TRS program
Biopharma | February 18, 2026

Newron Pharmaceuticals bags up to €38 million to fuel Phase III ENIGMA-TRS program

A final tranche of €12 million will follow, contingent on positive pivotal study results, with the share price calculated according to an agreed formula


Beyfortus cuts RSV hospitalizations across two seasons in landmark study
News | February 17, 2026

Beyfortus cuts RSV hospitalizations across two seasons in landmark study

The NIRSE-GAL study, conducted in Galicia, Spain, is the first real-world, population-based investigation of a universal RSV immunization program spanning two consecutive seasons


FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma
Drug Approval | February 17, 2026

FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma

Iberdomide has the potential to be the first approved CELMoD agent


Lilly’s Retevmo shows major survival boost in early-stage RET fusion lung cancer
Clinical Trials | February 17, 2026

Lilly’s Retevmo shows major survival boost in early-stage RET fusion lung cancer

The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease


Roche’s Gazyva hits major milestone in rare kidney disease
Clinical Trials | February 17, 2026

Roche’s Gazyva hits major milestone in rare kidney disease

Primary membranous nephropathy is a chronic autoimmune disease that attacks the kidneys’ filtering units


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


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


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