FDA
UK begins major trial for new inhaler-based COVID-19 treatment
Synairgen's SG018 trial is a randomised placebo-controlled study being conducted in approximately 20 countries enrolling a total of 610 COV...
Covid-19: USFDA warns against tweaking vaccine dosage
Suggestions to tweak dosage strategy to overcome a supply crunch are not rooted in solid evidence and hence such a move could put public he...
US may cut some Moderna vaccine doses in half to speed rollout, official says
"We know that for the Moderna vaccine, giving half of the dose to people between the ages of 18 and 55, two doses, half the dose, which mea...
Should vaccine volunteers now get the real thing?
Tens of thousands of Americans have volunteered to test COVID-19 vaccines, but only about half of them got the real thing during trials. No...
COVID-19 tested resilience of Maharashtra's healthcare system
According to Maharashtra's Health Minister Rajesh Tope, the state capital Mumbai has an extensive domestic and international air connectivi...
Security team for Philippines' Duterte gets unauthorised Chinese Covid-19 vaccine
China has four vaccines, including Sinopharm, in the final stages of development and is well advanced with mass human testing in a number o...
Explained: Where are we in the COVID-19 vaccine race?
The European Union gave approval on Dec. 21 for the COVID-19 vaccine developed by Pfizer Inc and BioNTech SE, the latest regulatory go-ahea...
Trump, ahead of FDA, says Moderna's COVID-19 vaccine has been approved
The FDA had not yet authorized emergency use of the vaccine, a Bloomberg reporter said on Twitter, citing the agency. FDA and Moderna did n...
J&J enrolls about 45,000 participants for late-stage COVID-19 vaccine trial
J&J also said it plans to submit an emergency use authorization application to the U.S. Food and Drug Administration (FDA) in February if t...
Moderna's COVID-19 vaccine clears first US FDA hurdle
FDA staff said a two-dose regimen of Moderna's vaccine was highly effective in preventing confirmed cases of COVID-19. The comments were ma...
US FDA authorizes Pfizer COVID-19 vaccine; Millions of doses to be shipped right away
FDA granted an emergency use authorization for the vaccine, developed with German partner BioNTech, which was shown to be 95% effective in ...
US FDA says working to authorize Pfizer vaccine fast
A panel of outside advisers to the FDA on Thursday voted overwhelmingly to endorse emergency use of the vaccine, paving the way for the age...
Single Covid-19 vaccine dose or double? Data put regulators in a fix
The US Food and Drug Administration has released its findings on the Pfizer/BioNtech efficacy data where it suggested that the vaccine at a...
Moderna expects emergency nod soon after FDA panel meet: CEO
The Food and Drug Administration is scheduled to hold the meeting on Dec. 17 to discuss the company’s request for emergency use authorisati...
BioNTech, Pfizer ask Europe to quickly approve virus vaccine
The German pharmaceutical company BioNTech and its U.S. partner Pfizer say they have submitted an application for speeded-up, conditional a...
US FDA approves first COVID-19 test kit for home use
The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples ...
India in dialogue with Moderna, other biotech firms over progress in COVID vaccine development: Sources
Moderna on Monday said the independent National Institutes of Health-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of...
IIT Roorkee scientists predict FDA-approved commercial drugs through AI to tackle COVID-19
Amid the rapid transmission of cases of Covid-19, a group of scientists from IIT Roorkee has leveraged Artificial Intelligence (AI) to pred...
USFDA issues warning to Shilpa Medicare for CGMP violations at Telangana plant
"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceutica...
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