Pfizer announces positive topline results from Phase 3 study of Hemophilia B gene therapy candidate

Alembic receives EIR for oncology injectable formulation facility at Panelav

This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers

USFDA completes pre-approval inspection of BHL's Vadodara facility

The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan

USFDA issues Form 483 for Parawada unit of Laurus Labs

The observation is procedural in nature and the company will address the observation within stipulated timelines.

USFDA approves Imjudo in combination with Imfinzi for liver cancer

Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib

Casper Pharma receives EIR from USFDA for its PAI

The inspection concluded with no observation (FDA-483) issued.

DME market across 7MM set to reach $11.1 billion in 2031, forecasts GlobalData