FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease

FDA nod to first oral single-dose treatment for gonorrhea

The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership

Sanofi flags delay in FDA review of Tolebrutinib for progressive multiple sclerosis

Neuren partner Acadia bags FDA go-ahead for new DAYBUE STIX powder for Rett Syndrome

The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga

Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma

The FDA aims to make a decision by April 8, 2026

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements

Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb