USFDA grants priority review to AstraZeneca-Daiichi Sankyo Enhertu for HER2-low, HER2 Ultralow Breast Cancer Ruchika Sharma3 Oct 2024 9:15 AM ISTAstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and...
AstraZeneca FluMist gets USFDA nod for self-administered influenza vaccine Ruchika Sharma21 Sept 2024 12:24 PM ISTAstraZeneca has announced that FluMist has been approved in the US as the self-administered influenza vaccine. FluMist, a needle-free nasal spray, was...
FDA approves Benralizumab for eosinophilic granulomatosis with polyangiitis Dr. Kamal Kant Kohli20 Sept 2024 9:45 AM ISTAstraZeneca's Fasenra (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with...
AstraZeneca Fasenra approved in China for severe eosinophilic asthma Ruchika Sharma23 Aug 2024 4:05 PM ISTCambridge: AstraZeneca's Fasenra (benralizumab) has been approved in China by the country's National Medical Products Association (NMPA) for the...
Daiichi Sankyo, AstraZeneca Enhertu gets USFDA breakthrough therapy designation for certain patients with HER2 low or HER2 ultralow metastatic breast cancer Ruchika Sharma21 Aug 2024 3:37 PM ISTTokyo: ENHERTU (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of unresectable...
CDSCO Panel Approves AstraZeneca's protocol amendment proposal for COPD drug Tozorakimab Dr. Divya Colin19 Aug 2024 5:45 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
AstraZeneca gets USD 107 million Pfizer verdict overturned in US cancer drug patent fight Ruchika Sharma19 Aug 2024 4:45 PM ISTCambridge: AstraZeneca has convinced a Delaware federal judge to throw out a jury's decision that the company owes USD 107.5 million for...
Imfinzi, Lynparza combo approved in EU for mismatch repair proficient advanced or recurrent endometrial cancer: AstraZeneca Ruchika Sharma18 Aug 2024 10:00 AM ISTCambridge: AstraZeneca's Imfinzi (durvalumab) and Lynparza (olaparib) have been approved in the European Union (EU) as treatment for certain...
AstraZeneca Imfinzi in combo with chemotherapy gets USFDA approval for treatment of resectable non-small cell lung cancer before and after surgery Ruchika Sharma17 Aug 2024 1:30 PM ISTCambridge: AstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult...
AstraZeneca Imfinzi gets USFDA priority review for limited-stage small cell lung cancer Ruchika Sharma16 Aug 2024 12:30 PM ISTCambridge: AstraZeneca's supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), based on the results from the positive...
50% of trial sites should be Govt sites, more subjects should be enrolled from Govt sites: CDSCO panel tells AstraZeneca on Baxdrostat study Dr. Divya Colin15 Aug 2024 5:45 PM ISTNew Delhi: In line with the drug major AstraZeneca's protocol amendment proposal to study the cardiovascular drug Baxdrostat, the Subject Expert...
AstraZeneca-Daiichi Sankyo Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer Ruchika Sharma15 Aug 2024 10:30 AM ISTCambridge: AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for...
