Zydus receives final approval from USFDA for Eltrombopag Tablets

Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad

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

Merck scores FDA nod for TGT drug Pimicotinib, promising new hope for patients

The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes

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

Bengaluru’s STEERLife and Bionpharma secure USFDA nod for generic HIV drug

Developed using STEERLife’s proprietary FragMelt continuous processing platform, the approval marks a major breakthrough in pharmaceutical manufacturing

FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning

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