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Tag: usfda

You Searched For "usfda"
Zydus Lifesciences secures USFDA okay for Lenalidomide Capsules to treat cancer

Zydus Lifesciences secures USFDA okay for Lenalidomide Capsules to treat cancer

Ruchika Sharma9 March 2023 3:15 PM IST
The drugs will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad.
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

USFDA classifies Jubilant Pharmova Nanjangud facility as Voluntary Action Indicated

Ruchika Sharma9 March 2023 2:15 PM IST
Noida: Jubilant Pharmova Limited has announced that pursuant to the United States Food and Drug Administration (USFDA) inspection of its API...
Cancer drug: Aurobindo Pharma arm Eugia Pharma gets USFDA approval for Lenalidomide Capsules

Cancer drug: Aurobindo Pharma arm Eugia Pharma gets USFDA approval for Lenalidomide Capsules

Ruchika Sharma9 March 2023 1:15 PM IST
The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone.
Alembic Pharma commissions new manufacturing facility in Pithampur to expand business

Alembic Pharma bags USFDA tentative nod for antidepressant drug Brexpiprazole

Ruchika Sharma9 March 2023 11:15 AM IST
Brexpiprazole Tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for treatment of...
USFDA grants priority review for Eisai Alzheimers drug LEQEMBI

USFDA grants priority review for Eisai Alzheimer's drug LEQEMBI

Ruchika Sharma8 March 2023 10:00 AM IST
Tokyo: Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics...
Sanofi successfully prices euro 1.5 billion bond issue

Sanofi Dupixent application for treatment of chronic spontaneous urticaria in adults, adolescents accepted for USFDA review

Ruchika Sharma7 March 2023 3:30 PM IST
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant.
USFDA approves intramuscular administration for Merck’s MMRV Family of Vaccines: M-M-RII, VARIVAX, ProQuad

USFDA approves intramuscular administration for Merck’s MMRV Family of Vaccines: M-M-RII, VARIVAX, ProQuad

Ruchika Sharma7 March 2023 11:22 AM IST
ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12...
Mesotherapy And Its Applications And Androgenetic Alopecia- Dr Sunil Kumar Prabhu

Mesotherapy And Its Applications And Androgenetic Alopecia- Dr Sunil Kumar Prabhu

Dr Sunil Kumar Prabhu6 March 2023 12:50 PM IST
Mesotherapy is a convenient, safe, and painless non-surgical procedure. It has found its way into the aesthetic world and is employed for various...
Alembic Pharma appoints Jigr Shah as Head - Business Finance

Alembic Pharma bags USFDA nod for Fluorouracil Injection

Ruchika Sharma6 March 2023 11:20 AM IST
Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric...
USFDA broadens indication for Eli Lillys Verzenio in HR+, HER2-, Node-Positive, High Risk Early Breast Cancer

USFDA broadens indication for Eli Lilly's Verzenio in HR+, HER2-, Node-Positive, High Risk Early Breast Cancer

Ruchika Sharma5 March 2023 4:30 PM IST
Verzenio (abemaciclib) is a targeted treatment known as a CDK4/6 inhibitor.
USFDA approves Zydus Lifesciences Infantile spasm drug Vigabatrin

USFDA approves Zydus Lifesciences Infantile spasm drug Vigabatrin

Ruchika Sharma4 March 2023 11:10 AM IST
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad.
USFDA updates Camzyos label to reduce echocardiography monitoring requirements, contraindications: Bristol Myers Squibb

USFDA accepts Bristol Myers Squibb sBLA for Opdivo for Resected Stage IIB/C Melanoma

Ruchika Sharma4 March 2023 10:00 AM IST
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin.
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