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    1. Business News
    2. About
    3. usfda

    USFDA

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    Gujarat govt favouring US firms with differential pricing for stents, AiMeD writes to Nadda
    Gujarat govt favouring US firms with differential pricing for stents, AiMeD writes to Nadda

    Aimed has also sought Nadda’s “urgent intervention” and “roll back the unfair discriminatory notification”.

    April 2, 2025 12:11 IST
    USFDA gives nod to first generics of Xarelto to treat stroke and heart disorders
    USFDA grants marketing authorisation of first home test for sexually transmitted infections

    The FDA reviewed this test under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk…

    March 30, 2025 10:55 IST
    USFDA gives nod to first generics of Xarelto to treat stroke and heart disorders
    FDA gives nod to first generics of Xarelto to treat stroke and heart disorders

    The approval is only for the 2.5mg tablet. Xarelto is also available in 10mg, 15mg, and 20mg tablets, as well…

    March 11, 2025 11:23 IST
    USFDA, Granola bars, granola bar risk, USFDA alerts, metal contamination, USFDA news, healthcare news, pharma news,
    FDA Alert: Millions of granola bars recalled over metal contamination; Classified as class II risk

    Certain batches of MadeGood granola bars were recalled due to the potential presence of a piece of metal in the…

    February 18, 2025 10:33 IST
    FDA gives nod to first rapid-acting insulin biosimilar for diabetes treatment
    FDA gives nod to first rapid-acting insulin biosimilar for diabetes treatment

    To date, the FDA has approved 65 biosimilar products for a variety of health conditions.

    February 15, 2025 12:49 IST
    USFDA, Ozempic, Ozempic news, Novo Nordisk, Novo Nordisk news, USFDA news, healthcare news, pharma news,
    USFDA gives nod to Novo Nordisk’s Ozempic to reduce risk of kidney failure

    Last month, the European Medicines Agency allowed Novo to add risk reduction for events related to kidney disease to the…

    January 29, 2025 10:11 IST
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    USFDA issues warning of serious allergic reaction with multiple sclerosis drugs; Urges patients to be cautious

    Patients should stop taking glatiramer acetate and seek immediate medical attention by going to an emergency room or calling 911…

    January 23, 2025 12:31 IST
    USFDA issues warning against use of anti-allergic nasal spray intravenously
    USFDA issues warning against use of anti-allergic nasal spray intravenously

    Recently in 2024, the agency received a report involving a patient who received the nasal solution as an injection.

    January 17, 2025 12:50 IST
    USFDA gives nod to Alembic Pharma's genetic formulation to treat heart failure
    USFDA gives nod to Alembic Pharma’s genetic formulation to treat heart failure

    Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 145.3 million for twelve months ending…

    November 12, 2024 16:44 IST
    USFDA, Decongestant, Decongestant usage, phenylephrine, phenylephrine side effects, USFDA news, healthcare news, pharma news,
    USFDA proposes removal of common decongestant from shelves after finding it ineffective

    The FDA would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from…

    November 8, 2024 12:44 IST
    USFDA gives nod to Alembic Pharma's generic formulation to treat heart disorder
    USFDA gives nod to Alembic Pharma’s generic formulation to treat heart disorder

    Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg have an estimated market size of US$ 28.2…

    October 21, 2024 11:25 IST
    USFDA gives nod to Pfizer's drug therapy for patients with Hemophilia
    USFDA gives nod to Pfizer’s drug therapy for patients with Hemophilia

    The FDA granted Hympavzi Orphan Drug designation for this application.

    October 14, 2024 11:34 IST
    USFDA gives nod to first over-the-counter home Flu and COVID-19 combination test
    USFDA gives nod to first over-the-counter home Flu and COVID-19 combination test

    According to USFDA, as with all rapid antigen tests, which generally have lower sensitivity than molecular tests, there is a…

    October 8, 2024 16:55 IST
    USFDA gives nod to Alembic Pharma's generic formulation to treat itchy eyes
    USFDA gives nod to Alembic Pharma’s generic formulation to treat itchy eyes

    Alembic has a cumulative total of 216 ANDA approvals (189 final approvals and 27 tentative approvals) from USFDA.

    October 4, 2024 14:25 IST
    Bristol Myers gets USFDA nod for new type of schizophrenia drug
    Bristol Myers gets USFDA nod for new type of schizophrenia drug

    Schizophrenia causes persistent delusions and hallucinations and significantly impairs the way patients perceive reality.

    September 27, 2024 18:26 IST
    Menopause, hot flashes, drug side effects, liver injury, Veozah side effects, Healthcare news, pharma news,
    Popular medicine to treat menopause-related hot flashes can lead to serious liver injury, FDA warns

    Patients should stop taking Veozah immediately and contact the doctor who prescribed the medicine if they experience signs and symptoms…

    September 13, 2024 17:23 IST
    Dietary Supplements, FDA warnings, USFDA news, Umary, Amazy, health news, wellness news,
    Don’t use THESE supplements as they are harmful to your health, FDA warns

    The agency recently issued a warning letter to SoloVital for selling Umary. In July 2024, Main Products and SoloVital recalled…

    September 6, 2024 15:57 IST
    USFDA grants tentative approval to Zydus' drug to treat Parkinson's Disease
    USFDA grants tentative approval to Zydus’ drug to treat Parkinson’s Disease

    The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ – II, India.

    August 28, 2024 11:51 IST
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    PM Modi to unveil Safran LEAP engine MRO unit in Hyderabad-why it matters
    PM Modi to unveil Safran LEAP engine MRO unit in Hyderabad-why it matters
    Business15 min ago

    PM Modi to inaugurate SAESI facility near Hyderabad Airport, a major milestone for India’s aviation sector. The facility will serve as Safran’s dedicated MRO centre for LEAP engines, marking the first time a global engine OEM has established an MRO operation in India. This move will boost India’s capabilities and position it as a global aviation and MRO hub.

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