Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company

AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease

If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option

Enveric clears FDA feedback milestone, prepares IND submission for EB-003

IND application for EB-003 expected in early 2026

Rona submits IND for GalNAc-conjugated siRNA targeting obesity

RN3161 is engineered to reduce fat while preserving lean mass, setting it apart from current treatment options

GC Biopharma submits IND to begin Phase 3 clinical trial for Barycela in Thailand

AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients

The submission is supported by positive results from the Phase 3 AMPLIFY trial

Johnson & Johnson submits additional data to FDA on psoriatic arthritis

The submission is supported by results from the Phase 3b APEX study

Bayer submits EU application for Gadoquatrane MRI contrast agent

It is intended for contrast enhancement in MRI scans

Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment

The submission is based on data from the STEP UP and STEP UP T2D clinical trials

SPARC announces submission of IND Application for SBO-154 to USFDA

The IND application supports the next phase of development of SBO-154