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Investigation detects lead in WanaBana Apple Cinnamon Fruit Puree

The FDA is advising consumers not to buy a brand of fruit puree pouches for children after the products were found to have high levels of lead.

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U.S. FDA joins global regulators probing tainted overseas cough syrup

In a statement, the FDA said it had no indication that contaminated syrups had entered the U.S. drug supply chain, but it is "investigating the potential impact and scope of this hazard on FDA-regulated products." The agency recommended consumers only take medicines which were made to be sold in the United States, especially for children. "The FDA is taking the international tragedy seriously and is making every effort to prevent contaminated product from entering the U.S. market and to identify dangerous products that may have been brought into the U.S.," the statement said.

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Health News Roundup: U.S. FDA panel to review Emergent's OTC opioid overdose drug; WHO urges travellers to wear masks as new COVID variant spreads and more

Reuters reported on Friday that China was in talks with Pfizer to secure a licence that will allow domestic drugmakers to manufacture and distribute a generic version of the U.S. firm's COVID-19 antiviral drug Paxlovid in China. WHO urges travellers to wear masks as new COVID variant spreads Countries should consider recommending that passengers wear masks on long-haul flights, given the rapid spread of the latest Omicron subvariant of COVID-19 in the United States, World Health Organization (WHO) officials said on Tuesday.

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Health News Roundup: U.S. FDA changes Plan B label to say it does not cause abortion; China's Zhejiang has 1 million daily COVID cases, expected to double and more

The consumer information distributed with the morning after pill known as Plan B One-Step, which has been available over the counter for everyone since 2013, now makes clear its mechanism of action does not alter the implantantion of an egg. China's Zhejiang has 1 million daily COVID cases, expected to double China's Zhejiang, a big industrial province near Shanghai, is battling around a million new daily COVID-19 infections, a number expected to double in the days ahead, the provincial government said on Sunday.

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Company prohibited from distributing drug products

On Monday, the U.S. District Court for the Western District of Oklahoma entered a consent decree against Qualgen LLC, an Edmond outsourcing facility with a history of violations.

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Juul to pay nearly $440M to states, including Oklahoma

Electronic cigarette maker Juul Labs has agreed to pay nearly $440 million to settle a two-year investigation by 33 states, including Oklahoma, related to marketing of its high-nicotine vaping products.

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Consumers Left to Find Alternatives After Major Food Companies Recall Multiple Products Across US

Americans have been hit hard this year with crushing recalls on essential items like baby formula, and household staples such as peanut butter.

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Health News Roundup: Heart, stroke risks climb after COVID-19; flu shots may be protective; Mexico posts 21,563 new COVID-19 cases, 568 more deaths and more

The European Medicines Agency said its safety committee had studied cases of menstrual disorders reported after vaccination, adding it had requested more data from vaccine developers to assess the issue. Australia suffers worst COVID day this year with millions in lockdown Australia saw a record daily number of new coronavirus cases this year on Saturday, with the country's most populous states of New South Wales, Victoria and Queensland recording a total of 361 cases of the highly infectious Delta variant.

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US: FDA issues emergency use for third COVID-19 vaccine

Biden says approval is 'exciting news for all Americans'
Servet Günerigök |
28.02.2021
WASHINGTON
The US Food and Drug Administration (FDA) issued emergency use authorization Saturday for Johnson & Johnson's vaccine to fight the coronavirus.
The agency said it determined the Janssen vaccine, third to be approved, met statutory criteria and its known and potential benefits outweigh the known and potential risks.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic,” said Acting FDA Commissioner Janet Woodcock.
The vaccine is administered as a single dose.

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Biocon Share Price: Biocon tanks 4% as USFDA defers decision on Avastin biosimilar application

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NEW DELHI: Shares of Biocon fell nearly 4 per cent in Monday's trade after the biotechnology major said that the US health regulator has deferred action on the biologics license application (BLA) for a biosimilar to drug Avastin, used to treat various types of cancers.
Following the development, the stock fell 3.89 per cent to hit a low of Rs 463.05 on BSE.
Biocon's arm Biocon Biologics and Mylan, a subsidiary of Viatris Inc, have been informed by the US Food and Drug Administration (USFDA) of a deferred action on the BLA for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), Biocon said in a regulatory filing.

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