Photo: Shutterstock
FDA Health Advisers Unanimously Approved Alzheimer's Drug Leqembi
Health advisors have unanimously backed the much-anticipated drug Leqembi. After receiving conditional approval in January, early results demonstrated Leqembi's efficacy in early-stage ofAlzheimer's disease. The FDA is currently reviewing more conclusive data to determine if the drug justifies full approval with final decision by July 6. Furthermore, with this, the new drug is likely to be introduced in market, for people in summers.
Tags: FDA, Drugs, Alzheimer's, Medical news, Patients
Courtesy: CNBC
Photo: Reuters
FDA Cancels Manufacture Of Baby Powder By J&J In Mumbai Plant Over Quality Standards
The Food and Drug Administration (FDA) has cancelled manufacturing of baby powder by Johnson and Johnson (J&J)’s in Mumbai's Mulund plant on Thursday as samples were unable to meet the standard quality parameter. The product may affect the health of the skin of the babies and has been recalled from the market. "For the safety of the public, we have cancelled the licence,” said an FDA official.
Tags: Johnson and Johnson, Baby powder, Maharashtra , Mumbai, FDA
Courtesy: The Indian Express
Photo: Fresherslive
Blood Bank Sealed Over 'Irregularities': Gurugram
Haryana's Food and Drug Administration Department sealed a private blood bank over "irregularities", in Gurugram's sector 56 on April 30. The department then filed a complaint in the jurisdictional police station, where an FIR has been filed against a doctor and an executive director of the blood bank. Reportedly, the raid was conducted after receiving inputs about "illegal activities" in the blood bank. Further details are awaited.
Tags: Blood Bank, Irregularities, Gurugram, FDA
Courtesy: Press Trust Of India
Photo: Hindustan Times
Covaxin Maker Seeks Approval In US For Children Under 18 Years
Bharat Biotech's partner Ocugen on November 6, asked the US Food and Drug Administration (FDA) for the emergency use authorisation of Covaxin for children under 18 years. Earlier the vaccine was granted approval by the World Health Organisation (WHO) for its Emergency Use Listing (EUL). "We are pleased to announce our EUA filing to the US-FDA through our partners-Ocugen,"… read-more
Tags: covid 19, Coronavirus, Covaxin, Bharat biotech, FDA
Courtesy: ANI
Photo: Time Magazine
Pfizer COVID Pills Highly Effective At Preventing Deaths; Suggests Trials
Pfizer on November 5, said that its experimental pill for COVID-19 reduced the rate of hospitalization and deaths of patients to nearly 90 percent. Reportedly, the drugmaker has recently joined in the race of making the world's first, easy consume medicine for Corona Virus in the United States. The company will be seeking approval from the FDA and international… read-more
Tags: covid-19 pill, covid 19, Vaccination, Pfizer, FDA
Courtesy: The Guardian
Photo: U.S. News
FDA To Evaluate Moderna Vaccine For Children Aged 12-17 By Jan 2022
Moderna Inc stated that US Food and Drug Administration (FDA) requested more time to finish its evaluation of the company's Covid-19 vaccine for teenagers aged 12-17 years on October 31. FDA evaluation may not be finished until January 2022, which might delay the issuance of an emergency use authorization (EUA)… read-more
Tags: Moderna, Covid-19, Covid Vaccine, FDA, children vaccine
Courtesy: Reuters
Photo: Reuters
Pfizer COVID Vaccine Shows 90.7% Efficacy In children: Report
Pfizer's clinical trial in children from the age of 5 to 11 years was not primarily designed to measure efficacy against the virus. Instead, it compared the amount of neutralizing antibodies induced by the vaccine in children to the response of older recipients in the adult trials. Based on the results the company said that their COVID-19 vaccine induced a robust immune response in children.
Tags: Covid-19, Covid-19 Vaccination, United States, FDA
Courtesy: Reuters
Photo: Deccan Herald
Drinking Raw Milk Isn't Healthy: Food and Drug Administration
As we all know that milk contains protein, calcium, nutrients, and enzymes but a question surely arises whether raw milk is good or boiled milk. According to Food and Drug Administration (USA), people should drink boiled milk because raw milk can ''cause food poisoning''. Also, raw milk includes many disadvantages such as it can harm those with weak immunity, infect deadly diseases and also increase acidity in the body.
Tags: Raw Milk, Boiled Milk, FDA, Immunity
Courtesy: News Daily India
Photo: Zee News
Covaxin Failed To Secure Emergency Use Authorisation In US
The emergency use authorisation of Bharat Biotech COVID-19 vaccine 'Covaxin' has been rejected by the US drug regulator. The company will now submit only a biologics license application for 'Covaxin'. Meanwhile, Bharat Biotech has decided to publish its phase-3 clinical trial data in July. Notably, 'Covaxin' has secured an approval in India and is one of those COVID vaccines which are being administered to people.
Tags: Bharat biotech, FDA, United States, Covaxin, Covid-19
Courtesy: Times Now
Photo: Vccircle
Indian Drugmaker Fined $50 Mn By US Govt For Irregularities
The US’ Department of Justice has fined an Indian drugmaker with $50 million for supplying low-grade active pharmaceutical ingredients used in cancer drugs distributed in the US. Reportedly, the Fresenius Kabi Oncology Limited (FKOL) had violated the Food and Drug Administration’s guidelines, concealed and spoiled records with FDA investigators. Moreover, the FDA said Active Pharmaceutical Ingredients produced at FKOL’s Bengal-based plant "… read-more
Tags: Indian drug manufacturer, FKOL, FDA, active pharmaceutical ingredients
Courtesy: The Indian Express
