Lupin receives approval from USFDA for Prasugrel Tablets, USP

Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer

First PARP inhibitor and new hormonal agent combination approved for these patients in Europe

Glenmark receives ANDA approval for Sodium Phenylbutyrate Tablets

Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.

Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation

Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint

Lupin receives approval from USFDA for Darunavir Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.

Aptar Pharma collaborates with Fluidda

The companies will leverage their respective proprietary technology platforms

Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA

Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA

USFDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.

Pfizer announces positive results from Phase 3 study of 20-valent pneumococcal conjugate vaccine

Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA