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  • US FDA begins inspection of Cipla's Pithampur unit Jun 27, 2022 01:29 PM IST

    US FDA begins inspection of Cipla's Pithampur unit

    The company has the FDA is doing a pre-approval inspection for drug application it made in the US

  • Not planning to inoculate children below 12 years for COVID: NTAGI on US vaccinating children under five Jun 23, 2022 02:57 PM IST

    Not planning to inoculate children below 12 years for COVID: NTAGI on US vaccinating children under five

    Experts say COVID vaccines in children may not provide any additional benefit as most have already developed immunity as they have been exposed to the infection earlier.

  • Oncologists welcome FDA’s proposal to limit nicotine in cigarettes, but say India has a long road ahead Jun 22, 2022 04:24 PM IST

    Oncologists welcome FDA’s proposal to limit nicotine in cigarettes, but say India has a long road ahead

    The oncologists feel that a huge political will is needed to establish nicotine level on tobacco products in India.

  • US seeks to limit nicotine levels in cigarettes Jun 22, 2022 07:12 AM IST

    US seeks to limit nicotine levels in cigarettes

    The Food and Drug Administration will draft a rule that limits nicotine, according to a notice of a proposed rule posted on the US Office of Information and Regulatory Affairs.

  • FDA advisers back Covid shots for kids under 5 Jun 16, 2022 06:28 AM IST

    FDA advisers back Covid shots for kids under 5

    The 21-member committee advising the Food and Drug Administration voted unanimously in favor of clearance for Pfizer’s three-dose vaccine for youngsters ages six months through 4 years.

  • FDA and Abbott reach agreement on baby formula to try to ease shortage May 17, 2022 08:13 AM IST

    FDA and Abbott reach agreement on baby formula to try to ease shortage

    The FDA said it expected Abbott to restart production in about two weeks. The agreement stems from a US Department of Justice complaint and consent decree with the company and three of its executives

  • Agatsa, world’s smallest ECG maker, eyes entry into US market next year Apr 29, 2022 06:05 PM IST

    Agatsa, world’s smallest ECG maker, eyes entry into US market next year

    Electronics engineer Neha Rastogi and Rahul Rastogi said Agatsa is working with different agencies for US FDA clearances and CE validations because of the high demand for small ECG machines in the international markets.

  • The FDA authorizes the first COVID-19 Breath Test Apr 15, 2022 10:37 AM IST

    The FDA authorizes the first COVID-19 Breath Test

    “Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

  • Rapid nose swab tests for COVID may not detect Omicron quickly enough-expert says Jan 08, 2022 08:58 AM IST

    Rapid nose swab tests for COVID may not detect Omicron quickly enough-expert says

    The agency said there are safety concerns regarding self-collection of throat swabs, "as they are more complicated than nasal swabs, and if used incorrectly, can cause harm to the patient."

  • FDA panel backs first-of-a-kind COVID-19 pill from Merck Dec 01, 2021 07:51 AM IST

    FDA panel backs first-of-a-kind COVID-19 pill from Merck

    A panel of US health advisers narrowly backed the benefits of a closely watched COVID-19 pill from Merck, setting the stage for a likely authorisation of the first drug that Americans could take at home to treat the virus.

  • Dr Reddy's gets FDA nod for generic Revlimid; Enjoys 180 days exclusivity Oct 19, 2021 12:16 PM IST

    Dr Reddy's gets FDA nod for generic Revlimid; Enjoys 180 days exclusivity

    According to a press release issued by the city-based drug maker, the FDA approved Lenalidomide capsules in 2.5 mg and 20 mg strengths and gave tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths. Lenalidomide is used to treat various types of cancers.

  • FDA panel takes up tough questions on Johnson & Johnson COVID-19 boosters Oct 16, 2021 08:26 AM IST

    FDA panel takes up tough questions on Johnson & Johnson COVID-19 boosters

    Unable to settle the best timing, the FDA’s advisory panel voted unanimously that the booster should be offered at least two months after people got their earlier shot.

  • 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.

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