Camurus’ Oclaiz NDA resubmission accepted by FDA

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026

FDA endorses Relmada’s registrational strategy for bladder cancer therapy

GRIN Therapeutics launches global Phase 3 trial for groundbreaking GRIN-NDD therapy

GRIN-NDD is one of the most complex neurodevelopmental disorders with limited treatment options today

FDA nod to first-ever treatment for fatal pediatric Menkes disease

Dr. Reddy’s launches first generic equivalent of extra-strength Pataday in US

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% is an antihistamine eye drop, indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander

EpiBiologics secures $107 million in Series B to advance tissue-selective cancer therapies

The therapy is mutation-agnostic and aims to overcome limitations of existing EGFR-targeting drugs by concentrating degradation in tumors while sparing healthy tissue

Teva and Royalty Pharma partner in $500 million deal to fast-track vitiligo treatment

Royalty Pharma to provide up to $500 million, including $75 million for Phase 2b funding

4Moving Biotech bags FDA nod to launch US trial of groundbreaking osteoarthritis therapy

Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function

Complement Therapeutics’ gene therapy gains FDA fast-track for vision loss treatment

CTx001 targets Geographic Atrophy (GA) secondary to Age-related Macular Degeneration

MRM Health scores FDA green light to launch Phase 2b trial of groundbreaking UC therapy

MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms