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

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 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

Metropolis Healthcare launches Genomics Centre to scale precision diagnostics and research

Backed by two CAP - accredited genomics labs in Delhi NCR and Mumbai, supporting oncology, reproductive health, neurology, transplant immunology, and rare diseases

Pfizer’s BRAFTOVI combo shows breakthrough results in aggressive colorectal cancer

The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population

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

FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning

Organon strikes deal with Daiichi Sankyo to launch breakthrough cholesterol drug in Northern Europe

This collaboration combines Organon’s commercial agility with Daiichi Sankyo’s expertise in cardiovascular innovation to bring Nilemdo to patients in France, Denmark, Iceland, Sweden, Finland and Norway

Alembic announces USFDA tentative approval for Bosutinib tablets