Zydus receives USFDA ODD for Desidustat for the treatment of sickle cell disease

This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease

Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors

Hologic’s Aptima HPV test bags FDA nod for primary cervical cancer screening

Hologic has been at the forefront of cervical cancer screening for decades

Zydus receives FDA’s tentative approval for Dapagliflozin Tablets

Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility

Inspection included drug device combinations covering our recent filing in nasal sprays domain

FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available

FDA launches PreCheck program to bring drug manufacturing back to US

The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites

Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway

NATCO receives FDA's tentative approval for Erdafitinib tablets

NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration