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  • US FDA grants full approval to Pfizer-BioNTech COVID-19 vaccine Aug 23, 2021 07:24 PM IST

    US FDA grants full approval to Pfizer-BioNTech COVID-19 vaccine

    This has made the two-shot Pfizer vaccine the first to receive full approval from the federal government.

  • US approves COVID-19 vaccine booster for those with weak immune systems Aug 13, 2021 09:06 AM IST

    US approves COVID-19 vaccine booster for those with weak immune systems

    The announcement by the Food and Drug Administration applies to millions of Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders.

  • FDA adds warning of rare reaction risk to Johnson & Johnson COVID-19 vaccine Jul 13, 2021 08:14 AM IST

    FDA adds warning of rare reaction risk to Johnson & Johnson COVID-19 vaccine

    The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness and occasionally paralysis. Health officials described the side effect as a “small possible risk" for those getting the shot.

  • Alzheimer's drug stirs hope for patients, worry for doctors Jun 27, 2021 06:58 PM IST

    Alzheimer's drug stirs hope for patients, worry for doctors

    The FDA approval isn't limited to those early patients. Anyone with Alzheimer's at least theoretically could get prescribed the drug. But advocacy groups like the Alzheimer's Association and many doctors say the focus should be patients with an early diagnosis.

  • FDA adds warning about rare heart inflammation to Pfizer, Moderna COVID shots Jun 26, 2021 11:26 AM IST

    FDA adds warning about rare heart inflammation to Pfizer, Moderna COVID shots

    For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said.

  • Bharat Biotech won't seek emergency nod for Covaxin in US, to apply for full approval Jun 11, 2021 08:39 AM IST

    Bharat Biotech won't seek emergency nod for Covaxin in US, to apply for full approval

    Bharat Biotech’s American partner Ocugen has dropped the plan to seek an emergency approval for the coronavirus jab based on a recommendation from the US FDA.

  • Texas hospital workers protest a mandatory vaccine policy Jun 08, 2021 04:14 PM IST

    Texas hospital workers protest a mandatory vaccine policy

    While the Centers for Disease Control and Prevention recommends health care workers get a flu shot, and some hospital systems require it, few companies have required COVID-19 shots, despite federal government guidance that says employers can mandate vaccines for on-site workers.

  • Explained: What does FDA approval of Biogen's Alzheimer's drug mean for patients? Jun 08, 2021 09:46 AM IST

    Explained: What does FDA approval of Biogen's Alzheimer's drug mean for patients?

    The FDA approved Aduhelm for the treatment of Alzheimer's disease. The decision did not define the patient population for whom the treatment is appropriate.

  • Black Fungus: Cheaper alternative treatment picking up amid drug shortage May 24, 2021 02:03 PM IST

    Black Fungus: Cheaper alternative treatment picking up amid drug shortage

    In black fungus treatment, liposomal amphotericin B is the drug of choice for most doctors as it does not have side-effects associated with the conventional alternative but is in short supply.

  • COVID-19 Vaccine | FDA inspection found problems at factory making J&J vaccine Apr 21, 2021 09:52 PM IST

    COVID-19 Vaccine | FDA inspection found problems at factory making J&J vaccine

    The Food and Drug Administration released a statement and a 13-page report detailing findings from its recent inspection of the now-idle Emergent Biosciences factory.

  • Beware of COVID-19 scams as vaccine approaches FDA approval Nov 30, 2020 07:47 PM IST

    Beware of COVID-19 scams as vaccine approaches FDA approval

    Homeland Security investigators are working with Pfizer, Moderna and dozens of other drug companies racing to complete and distribute the vaccine and treatments for the virus. The goal: to prepare for the scams that are coming, especially after the mess of criminal activity this year with phony personal protective equipment, false cures and extortion schemes.

  • US FDA grants emergency use authorisation to Regeneron COVID-19 antibody given to Trump Nov 22, 2020 07:46 AM IST

    US FDA grants emergency use authorisation to Regeneron COVID-19 antibody given to Trump

    The US Food and Drug Administration on Saturday issued emergency use authorization for Regeneron Pharmaceuticals Inc's COVID-19 antibody therapy..

  • Controversial Alzheimer’s drug faces critical test before FDA panel Nov 06, 2020 10:11 PM IST

    Controversial Alzheimer’s drug faces critical test before FDA panel

    The drug, aducanumab, would not stop or reverse dementia, but some evidence suggests it can slow the progression of memory and thinking problems in people with mild or early symptoms of cognitive decline.

  • FDA issues warning Letter to Mylan's Telangana plant; Company says no impact Sep 03, 2020 12:37 PM IST

    FDA issues warning Letter to Mylan's Telangana plant; Company says no impact

    Hyderabad, Sep 3 : The US Food and Drug Administration has issued a Warning Letter to Mylan Laboratories Limited's plant in Telangana for signific..

  • Coronavirus update: Abbott's card-sized 15-minute COVID-19 test gets US FDA nod for emergency use Aug 27, 2020 09:45 AM IST

    Coronavirus update: Abbott's card-sized 15-minute COVID-19 test gets US FDA nod for emergency use

    Abbott will also launch a mobile app NAVICA which will allows people to store, access and display their COVID-19 test results.

  • Coronavirus News | FDA ‘grossly misrepresented’ blood plasma data, scientists say Aug 25, 2020 08:17 AM IST

    Coronavirus News | FDA ‘grossly misrepresented’ blood plasma data, scientists say

    Over the next couple of months, as data emerges from vaccine clinical trials, the safety of potentially millions of people will rely on the scientific judgment of the FDA

  • Coronavirus treatment: US FDA gives emergency use authorisation to administer plasma therapy Aug 24, 2020 09:06 AM IST

    Coronavirus treatment: US FDA gives emergency use authorisation to administer plasma therapy

    US President Donald Trump said plasma therapy could reduce COVID-19 deaths by 35 percent in a country that has witnessed over 1.7 lakh fatalities due to the pandemic already.

  • Donald Trump says he is taking hydroxychloroquine despite FDA warning May 19, 2020 10:05 AM IST

    Donald Trump says he is taking hydroxychloroquine despite FDA warning

    Trump volunteered the disclosure during a question-and-answer session with reporters at the White House as he met restaurant executives whose businesses are reeling from the impact of the virus.

  • FDA cracks down on sale, manufacture of substandard sanitisers Mar 13, 2020 11:30 AM IST

    FDA cracks down on sale, manufacture of substandard sanitisers

    People should purchase only high-quality hand sanitisers and hand wash and that too with proper bills. They should avoid getting cheated by buying substandard products

  • Europe 'panicking' over India's pharmaceutical export curbs: Industry group Mar 04, 2020 02:55 PM IST

    Europe 'panicking' over India's pharmaceutical export curbs: Industry group

    India, the world's main supplier of generic drugs, has restricted the export of 26 active pharmaceutical ingredients (APIs) and the medicines made from them.

  • Health | India must close the tortuous discussions on medical device regulation Nov 04, 2019 03:42 PM IST

    Health | India must close the tortuous discussions on medical device regulation

    Niti Aayog’s Medical Devices (Safety, Effectiveness and Innovation) Bill is the latest in India's seemingly never-ending attempt to introduce a comprehensive and effective medical device regulation, which seems to be reaching a jubilee year of sorts.

  • CDC, FDA report 215 cases of respiratory illness possibly tied to vaping Aug 31, 2019 04:30 PM IST

    CDC, FDA report 215 cases of respiratory illness possibly tied to vaping

    The number of cases rose to 215 as of Aug. 27, from the US Centers for Disease Control and Prevention's (CDC) last update of 193 cases last week.

  • Indian drug makers show improvement in USFDA inspection outcomes Mar 01, 2019 04:32 PM IST

    Indian drug makers show improvement in USFDA inspection outcomes

    According to USFDA data, out of 174 inspections in 2018 only 4 percent inspections are classified as OAI, attracting agency’s regulatory and administrative action such as withholding new approvals, warning letter and import alert, in contrast to 15 percent in 2017.

  • Closely monitoring online food businesses, says Maharashtra FDA commissioner Feb 26, 2019 07:15 PM IST

    Closely monitoring online food businesses, says Maharashtra FDA commissioner

    The ice cream industry is expected to continue to grow at 15-20 percent.

  • Food adulterers will face life sentence: Maharashtra government Nov 22, 2018 02:52 PM IST

    Food adulterers will face life sentence: Maharashtra government

    Food and Civil Supplies Minister Girish Bapat informed the Legislative Council that the government would amend the existing law, to provide for life imprisonment to offenders.

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