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Results For "FDA"

2075 News Found

Zydus receives final approval from USFDA for Lacosamide injection
Drug Approval | July 01, 2022

Zydus receives final approval from USFDA for Lacosamide injection

Lacosamide Injection is used to treat partial-onset seizures.


ANI Pharmaceuticals gets FDA approval of Clorazepate Dipotassium Tablets USP
Drug Approval | June 24, 2022

ANI Pharmaceuticals gets FDA approval of Clorazepate Dipotassium Tablets USP

ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.


Glenmark Pharmaceuticals to address USFDA’s observation
News | June 23, 2022

Glenmark Pharmaceuticals to address USFDA’s observation

U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi


Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant
Drug Approval | June 23, 2022

Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients


LG Chem’s new drug for obesity receives additional orphan drug designation by US FDA
News | June 16, 2022

LG Chem’s new drug for obesity receives additional orphan drug designation by US FDA

With this designation, LG Chem will receive benefits such as exclusive sales rights in the US market for seven years, subsidies and tax cuts for clinical testing costs in the US, and preliminary consulting support related to development


Eli Lilly gets FDA approval for alopecia drug
Drug Approval | June 15, 2022

Eli Lilly gets FDA approval for alopecia drug

Alopecia areata usually presents as a few small bald patches in the head


FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer
Drug Approval | June 14, 2022

FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer

Acceptance based on results from the phase 3 KEYNOTE-091 trial


Alembic receives USFDA tentative approval for Dasatinib tablets
Drug Approval | June 12, 2022

Alembic receives USFDA tentative approval for Dasatinib tablets

Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive


Strides receives USFDA approval for Ibuprofen OTC oral suspension
Drug Approval | June 12, 2022

Strides receives USFDA approval for Ibuprofen OTC oral suspension

Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.


Sanofi Dupixent gets USFDA nod for atopic dermatitis
Drug Approval | June 10, 2022

Sanofi Dupixent gets USFDA nod for atopic dermatitis

Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood