COVID-19: 35 pharma cos to mass product generic version of Pfizer's Paxlovid MD Bureau18 March 2022 6:16 PM ISTIn India, Hyderabad-based pharma major Aurobindo Pharma has signed the agreement.
Bayer Submits Application for NUBEQA to USFDA and EMA MD Bureau12 March 2022 2:45 PM ISTBayer today announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration USFDA as well as the submission...
Pfizer COVID pill for high-risk patients get EU drug regulator nod Ruchika Sharma30 Jan 2022 9:45 AM ISTNew Delhi: The European Union's drug regulator on Thursday gave the green light to Pfizer Inc's antiviral COVID-19 pill for treating adults at...
Merck seeks EMA to authorize Covid-19 pill Molnupiravir Hina Zahid25 Nov 2021 10:00 AM ISTNew Delhi: The European Medicines Agency said it has received a request from Merck to authorise its coronavirus antiviral, the first pill shown to...
No application received from SII for Covishield authorisation: EMA Ruchika Sharma17 July 2021 4:23 PM ISTNew Delhi: The European Medicines Agency (EMA) said it has not received any application from the COVID-19 vaccine Covishield maker Serum Institute of...
Covishield to get EMA approval in a month: Serum Institute CEO Adar Poonawalla Ruchika Sharma1 July 2021 10:00 AM ISTNew Delhi: Serum Institute of India is confident of receiving approval from the European Medicines Agency (EMA) for its COVID-19 vaccine Covishield in...
Sputnik V vaccine developers demand apology from EMA for negative comments on EU states directly approving Covid vaccine Ruchika Sharma10 March 2021 1:38 PM IST"After postponing Sputnik V review for months, EMA does not have the right to undermine (the) credibility of 46 other regulators that reviewed all the...
COVID-19 Vaccine: European regulator asks caution on Sputnik V Ruchika Sharma8 March 2021 5:26 PM ISTZurich: A senior European Medicines Agency (EMA) official urged European Union members on Sunday to refrain from granting national approvals for...
Gilead remdesivir not associated with kidney problems in COVID-19 patients: European panel Ruchika Sharma14 Feb 2021 10:00 AM ISTNew Delhi: Europe's drugs regulator said on Friday its safety panel found no evidence that Gilead's remdesivir caused kidney problems in some COVID-19...
Hackers manipulated stolen Covid-19 vaccine data to undermine trust: EMA Ruchika Sharma20 Jan 2021 12:49 PM ISTThe leaked Covid-19 data includes internal/confidential email correspondence dating from November, relating to evaluation processes for the vaccines.
COVID-19 vaccine documents unlawfully accessed in EMA cyberattack: Moderna Ruchika Sharma15 Dec 2020 1:33 PM ISTNew Delhi: Moderna Inc said on Monday it was informed by the European Medicines Agency (EMA) certain documents related to pre-submission talks of its...
Diabetes Management: Biocon, Mylan drug Kixelle gets positive opinion from European Medicines Agency Ruchika Sharma14 Dec 2020 4:08 PM ISTNew Delhi: Biotechnology firm Biocon on Monday said its subsidiary Biocon Biologics and Mylan have received a positive opinion from the European...
