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

Dr. Reddy's Laboratories launches Lenalidomide Capsules in the U.S.

Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S.

Hikma launches seasonal allergic rhinitis nasal spray RYALTRIS in the US

This launch builds upon Hikma’s leading position as one of the largest US providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the US

Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility

The RRA was conducted from 22nd August, 2022 to 26th August, 2022.

Casper Pharma completed USFDA pre-approval inspection

The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.

FDA approval of deep brain stimulators will drive APAC market, says GlobalData

Abbott has recently received the US Food and Drug Administration nod to use its DBS device for treatment-resistant depression