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231 News Found

Ovation.io and PrecisionLife team to develop drug-response biomarkers for GLP-1 therapies
R&D | November 28, 2025

Ovation.io and PrecisionLife team to develop drug-response biomarkers for GLP-1 therapies

GLP-1 therapies are among the fastest-growing drug classes worldwide, projected to drive a $95 billion obesity market by 2030


FDA updates label for Sun Pharma’s UNLOXCYT, highlighting durable responses in advanced skin cancer
Clinical Trials | November 27, 2025

FDA updates label for Sun Pharma’s UNLOXCYT, highlighting durable responses in advanced skin cancer

The update reflects long-term clinical trial data showing that many patients with mCSCC or laCSCC experienced lasting responses


Otsuka files FDA application for first-in-class ADHD drug
Clinical Trials | November 27, 2025

Otsuka files FDA application for first-in-class ADHD drug

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor


Contineum MS drug stumbles in mid-stage trial
Clinical Trials | November 24, 2025

Contineum MS drug stumbles in mid-stage trial

Topline results from the Phase 2 VISTA trial show that PIPE-307 did not meet its primary or secondary efficacy endpoints


Roche’s Giredestrant sets new benchmark in early breast cancer treatment
Clinical Trials | November 19, 2025

Roche’s Giredestrant sets new benchmark in early breast cancer treatment

The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in invasive disease-free survival


ImmunoScape inks agreement with Cue Biopharma to launch next-gen cancer immunotherapy
Biopharma | November 16, 2025

ImmunoScape inks agreement with Cue Biopharma to launch next-gen cancer immunotherapy

The modular platform not only targets solid tumors but could also enhance traditional autologous and in vivo T cell therapies


FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma
Drug Approval | October 29, 2025

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability


MIRA Pharmaceuticals advances oral Ketamir-2 into Phase 1 MAD study for chemotherapy-induced neuropathic pain
Clinical Trials | October 29, 2025

MIRA Pharmaceuticals advances oral Ketamir-2 into Phase 1 MAD study for chemotherapy-induced neuropathic pain

Advancing toward Phase 2a evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track designation


FDA approves Tezspire for chronic rhinosinusitis with nasal polyps
Drug Approval | October 21, 2025

FDA approves Tezspire for chronic rhinosinusitis with nasal polyps

Approval broadens indication for Tezspire to a second disease characterized by epithelial-driven inflammation