Key Points
Nov 9 (Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday approved Valneva's (VLS.PA) single-shot vaccine for individuals 18 years of age and older who are at increased risk of exposure to the chikungunya virus...
Valneva's vaccine, with the brand name Ixchiq, is the first preventive shot to be approved in the United States for the mosquito-borne disease...
The FDA's decision is based on late-stage trials, which showed the vaccine was able to induce antibody levels that could neutralize the chikungunya virus in 98.9% of participants for 28 days post-vaccination...
The health regulator, however, asked the company to conduct a post-marketing study to assess the risk of severe chikungunya-like adverse reactions following administration of Ixchiq...
You might be interested in
First vaccine to prevent disease caused by chikungunya virus approved
13, Nov, 23The first-approved vaccine against chikungunya is intended for individuals aged 18 and older who face an elevated risk of exposure to the virus.
World's 1st vaccine against chikungunya primed for launch in India, says French drugmaker Valneva
16, Nov, 23VLA1553, commercially known as Ixchiq, has received USFDA clearance and will be launched in India — which has seen high number of chikungunya cases — after ‘regulatory talks with DCGI’.
First chikungunya vaccine, Ixchiq, approved by US Food and Drug Administration
10, Nov, 23The most commonly reported side effects were headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site, says the federal agency. Ixchiq, the first chikungunya vaccine, has been approved by the US Food and Drug Administration (FDA) for individuals 18 years of age and older who are at increased risk of exposure to mosquito-borne virus.
Apellis Pharma's eye-disorder drug gets FDA approval
19, Feb, 23The U.S. Food and Drug Administration has approved Apellis Pharmaceuticals Inc's drug to treat an advanced eye disorder that is one of the leading causes of blindness globally, the company said on Friday.
The first chikungunya vaccine could be a game changer in global health
17, Nov, 23The FDA's approval of a chikungunya vaccine brings hope to regions facing the highest risk of the mosquito-borne virus that has affected over 110 countries.
US approves first vaccine against chikungunya virus
10, Nov, 23Chikungunya, which causes fever and severe joint pain, is most prevalent in tropical and subtropical regions of Africa, southeast Asia and part of the Americas. | World News
US FDA asks to not purchase certain eye drops due to infection risk
28, Oct, 23The U.S. Food and Drug Administration on Friday issued a warning to consumers to not purchase or use certain eye drops from several major brands due to the risk of eye infection.
US regulators inspect Dr Reddy's, other Indian pharma majors
05, Dec, 23The U.S. Food and Drug Administration is inspecting Dr Reddy's (REDY.NS) research and development centre in the southern Indian city of Hyderabad, the pharma company said on Tuesday.
US approves first Chikungunya vaccine amid growing global health concerns
10, Nov, 23The US FDA has approved the world's first Chikungunya vaccine, Ixchiq, developed by Valneva. An application for authorisation has also been sent to the European Medicines Agency