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FDA VACCINE APPROVAL
Plan in the works to let hospitals import med equipment directlyIndia's drug regulator is proposing to allow hospitals to directly import advanced medical equipment like MRI and CT scanners, bypassing cu...- Piyush Goyal meets Ernst & Young CEO, discusses India's role in global supply chainsUnion Minister Piyush Goyal said he held a meeting with Janet Truncale, Global Chair and CEO of EY, to discuss India's growing role in glob...
- FDA drug center head fired after commissioner's exit, replaced by DavisThe U.S. Food and Drug Administration's drug center sees a leadership change as acting head Tracy Beth Hoeg departs, replaced by deputy Mic...
- Compliance squeeze, global scrutiny redefine India’s $30 billion pharma export playbookAs global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.
- White House favours former deputy surgeon general to lead CDC, Washington Post saysThe White House is considering Erica Schwartz to lead the CDC amid ongoing leadership changes, with additional senior appointments also und...
- Moderna says FDA will consider new flu shot after resolving public disputeThe FDA will now consider Moderna's mRNA flu vaccine application after a dispute over clinical trial design. Moderna agreed to seek full ap...
- US FDA reverses course, will review Moderna's revised flu vaccine applicationThe US Food and Drug Administration will now review Moderna's influenza vaccine. This comes after an initial refusal due to trial design is...
- Moderna pulls application for COVID-flu combination shotModerna has withdrawn its application for a combination flu and COVID vaccine, awaiting efficacy data from a late-stage influenza shot tria...
- New Trump vaccine policy might limit access to your future COVID shots: 10 pointsThe US Food and Drug Administration changes Covid-19 vaccine approval process. Access to seasonal boosters is restricted for healthy indivi...
- Moderna seeks US FDA approval for Omicron Covid booster for children over 6 yearsIn a request to the Food and Drug Administration (FDA), Boston-based biotech has requested that omicron shots be approved for teenagers age...
- Pfizer's COVID-19 vaccine just received full FDA approval. Here's what it meansIn early August, a Wall Street Journal report stated that India was in talks to buy 50 million doses of Pfizer and German partner BioNTech ...
- US regulators give full approval to Pfizer COVID-19 vaccineThe vaccine made by Pfizer and its partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has ...
- Pfizer-BioNTech Covid vaccine wins landmark US approvalAround 52% of the country is fully vaccinated, but health authorities have hit a wall of vaccine hesitant people, impeding the national cam...
- Pfizer, BioNTech seek full US approval for Covid-19 vaccineThe two pharma companies plan to submit data in support of the application "on a rolling basis over the coming weeks" to the Food and Drug ...
- FDA warns against one-dose regimen for coronavirus vaccinesIn February, some scientists and lawmakers suggested using a one-dose regimen for all coronavirus vaccines approved in the US, after certai...
- Trump, ahead of FDA, says Moderna's COVID-19 vaccine has been approvedThe FDA had not yet authorized emergency use of the vaccine, a Bloomberg reporter said on Twitter, citing the agency. FDA and Moderna did n...
- US medical experts recommend emergency authorisation of Pfizer COVID vaccineAn emergency use authorisation (EUA) is short of a full approval. Pfizer would have to file a separate application for full FDA approval fo...
- Questions over AstraZeneca's COVID-19 vaccine data risk delaying approvalSeveral scientists have raised doubts about the robustness of results showing the shot was 90% effective in a sub-group of trial participan...
- Do high-risk groups get priority over others? Emergency use of a Covid-19 vaccine explainedDuring a health crisis, the FDA can loosen its normal scientific standards.
- Joe Biden announces new Covid-19 task force under Vivek MurthyMurthy in the past has advocated a science-based approach to the pandemic and often cautioned against politics and politicians dictating pa...
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