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  • Lupin gets Health Canada approval of Tiotropium Bromide

    Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

  • FDA approves sotagliflozin for treatment of Heart Failure

    Lexicon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved INPEFA (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with :
    heart failure or
    type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

  • Milvexian of Janssen Pharmaceutical granted U.S. FDA fast track designation

    The Janssen Pharmaceutical Companies of Johnson & Johnson announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients.

  • FDA approved Xacduro for pneumonias caused by Acinetobacter

    The U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older.

  • J&J settled law suits over Amgen for Stelara

    Johnson & Johnson has settled its lawsuit over Amgen's proposed biosimilar version of J&J's top-selling treatment Stelara for psoriasis and other autoimmune conditions, according to a filing in Delaware federal court.

    Amgen said in a statement on Tuesday that the settlement terms are confidential, but it will allow the company to sell its biosimilar of Stelara "no later than January 1st, 2025."

  • FDA-approved Alzheimer’s drug lecanemab could prevent free-floating amyloid beta fibrils from damaging the brain

    For the first time, researchers described the structure of a special type of amyloid beta plaque protein associated with Alzheimer’s disease (AD) progression. In a report published May 10 in the journal Neuron, scientists showed the small aggregates of the amyloid beta protein could float through the brain tissue fluid, reaching many brain regions and disrupting local neuron functioning.  The research also provided evidence that a newly approved AD treatment could neutralize these small, diffusible aggregates.

  • Dr. Reddy’s Lab gets SEC recommendation for Lenalidomide

    Dr. Reddy’s Lab gets subject expert committee (SEC- Oncology & Haematology) recommendation for Lenalidomide Capsule. The 148th meeting was held on 11.05.2023 at CDSCO (HQ) New Delhi.

    Dr. Reddy’s Lab presented the proposal for manufacturing and marketing permission of Lenalidomide Capsule 25mg (using Lenalidomide povidone premix) along with the results of the BE study before the committee.

  • Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection

    Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Ephedrine Sulfate Injection USP, 50 mg/mL single-dose vials (USRLD: Akovaz® Injection).

    Ephedrine Sulfate Injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara (India).

  • Astellas VEOZAHTM (fezolinetant) approved by USFDA for Treatment of Vasomotor Symptoms Due to Menopause

    Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12. VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause.

  • Zydus receives EIR for the Pre-Approval Inspection at the manufacturing facility in Moraiya, Ahmedabad

    The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 23000 people worldwide and is driven by its mission to unlock new possibilities in life- sciences through quality healthcare solutions that impact lives.

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