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581 News Found

Astellas submits new drug application for Zolbetuximab in Japan
News | June 13, 2023

Astellas submits new drug application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers


Keytruda+ chemotherapy improves overall survival versus chemotherapy alone for unresectable advanced pleural mesothelioma
Clinical Trials | June 05, 2023

Keytruda+ chemotherapy improves overall survival versus chemotherapy alone for unresectable advanced pleural mesothelioma

In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone


Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST
Biotech | June 03, 2023

Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST

Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors


Pfizer’s phase 3 studies of novel antibiotic combination offer new hope for patients with multidrug-resistant infections and treatment options
Clinical Trials | June 02, 2023

Pfizer’s phase 3 studies of novel antibiotic combination offer new hope for patients with multidrug-resistant infections and treatment options

Data support that antibiotic aztreonam-avibactam (ATM-AVI) is effective and well-tolerated in treating infections caused by Gram-negative bacteria, with a similar safety profile to aztreonam alone


Concept Medical gets 4th IDE approval from USFDA
Drug Approval | May 31, 2023

Concept Medical gets 4th IDE approval from USFDA

For the treatment of Superficial Femoral Artery


Moderna presents Phase 1/2 of MRNA-3927at 2023 ASGCT Meeting
Clinical Trials | May 20, 2023

Moderna presents Phase 1/2 of MRNA-3927at 2023 ASGCT Meeting

First clinical trial reporting results of an mRNA therapeutic for intracellular protein replacement


USFDA puts on hold Sun Pharma trials on dermatological drug
Drug Approval | May 04, 2023

USFDA puts on hold Sun Pharma trials on dermatological drug

Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose


USFDA Advisory Committee votes  n Lynparza plus Abiraterone and Prednisone  for prostate cancer
Drug Approval | May 03, 2023

USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients


Lilly's Lebrikizumab shows improved face or hand dermatitis
Clinical Trials | May 02, 2023

Lilly's Lebrikizumab shows improved face or hand dermatitis

Lebrikizumab is an investigational high-affinity and potent IL-13 inhibitor being studied in adult and adolescent patients


Vaniam appoints Paula Franson to lead Clinical Strategy & Solutions
People | April 18, 2023

Vaniam appoints Paula Franson to lead Clinical Strategy & Solutions

Franson will help biopharma clients design a phased approach to inform and execute clinical development plans