Astellas updates on Fezolinetant application in US

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients

USFDA completes regulatory inspection of Natco's Vizag formulation facility

At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure

ExeGi Pharma gets clearance of IND application for EXE-346 a Live biotherapeutic biologic drug

This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis

Astellas announces hold lifted by FDA on Fortis clinical trial of AT845

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial

Moderna and CytomX partner for mRNA-based conditnionally activated therapeutics

Collaboration to generate and develop therapeutics for oncology and non-oncology conditions

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

MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting

Synchron raises $75 mn Series C Led by ARCH Venture Partners

Gates Frontier, Bezos Expeditions, Reliance Digital Health Limited, Greenoaks, Alumni Ventures, Moore Strategic Ventures, and Project X join ARCH as new additional investors