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U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plantThe U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Find...- A hidden warning in your snack bowl? Popular Potato Chips recalled over salmonella risk—what to check before your next biteThe bacteria linked to the recall, Salmonella, can present serious health risks, particularly for children, older adults and people with we...
- US judge rejects Bayer bid to block Johnson & Johnson prostate cancer drug claimsA US judge has dismissed Bayer's plea to halt Johnson & Johnson's advertising for its prostate cancer drug Erleada. Bayer alleged false cla...
- 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...
- US Stocks: ImmunityBio shares drop 20% on FDA warning letter over cancer therapy claims in adShares of ImmunityBio fell 20% on Tuesday after the U.S. Food and Drug Administration issued a warning letter that said a television advert...
- Sarepta shares fall 7% after gene therapy maker pauses Elevidys shipments in USShares of Sarepta Therapeutics fell nearly 7% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pau...
- US FDA fires most negotiators for pharma user fee talks, sources sayMass layoffs at the FDA, including senior negotiators, have disrupted the process of reauthorizing user fee programs that fund the agency's...
- US FDA asks fired scientists to return, including some reviewing Elon Musk's NeuralinkAt least 11 employees working at the FDA's Center for Devices and Radiological Health - which oversees medical device reviews - have receiv...
- US government employees sacked by Donald Trump administration. What do we know so farUS FDA did not immediately respond to request for comments outside regular business hours.
- Australia's Mayne Pharma sues Indian drugmaker Sun Pharma over patent infringementMayne Pharma sued India's Sun Pharma for allegedly infringing patents on IMVEXXY, a drug for menopause-related vaginal pain. The lawsuit wa...
- Elon Musk's Neuralink cited by FDA over animal lab issuesThe inspectors identified quality control lapses at the company's California animal research facility. A similar inspection at Neuralink's ...
- Indian eyedrop maker issues recall of various eye drops in US for potential safety reasonsKilitch Healthcare India Limited has recalled 27 types of eye drops sold in the U.S. due to safety concerns arising from insanitary conditi...
- FDA warns consumers of infection risk in over-the-counter eyedropsThe FDA warns against using over two dozen over-the-counter eyedrops due to infection risk, potentially leading to blindness. This advisory...
- Pfizer vaccine for children under five may be available in U.S. by end of FebruaryThe report says that the FDA urged the companies to submit the application so that regulators could begin reviewing the two-shot data.
- 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 Congressmen seek briefing on contaminated drugs from India, ChinaA bipartisan group of powerful US lawmakers Wednesday sought a congressional briefing on contaminated drugs from India and China used in th...
- Sun Pharma Halol site being inspected by US FDA: SourcesOver its recent call with investors, Sun Pharma management had maintained that the remediation exercise at the site have been completed and...
- Ranbaxy Laboratories withdraws applications of 27 drugs filed with USFDARanbaxy Laboratories has agreed to withdraw applications of 27 drugs filed with the US Foods and Drug Administration.
- Experts urge US to restrict drug AvandiaA majority of members of a key advisory committee recommended Wednesday that the US government allow diabetes drug Avandia to stay on the m...
- State FDA pulls plug on Wockhardt insulin drugThe state Food and Drug Administration (FDA) has ordered Wockhardt to withdraw its diabetic drug Wosulin from the state.
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