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Results For "approvaL"

2683 News Found

Zydus receives final approval from USFDA for Leuprolide Acetate injection
Drug Approval | November 15, 2025

Zydus receives final approval from USFDA for Leuprolide Acetate injection

Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer


Zydus receives FDA final approval for Diroximel fumarate delayed-release capsules, 231 mg
Drug Approval | November 14, 2025

Zydus receives FDA final approval for Diroximel fumarate delayed-release capsules, 231 mg

Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis


Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg
Drug Approval | November 14, 2025

Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg

Dexlansoprazole delayed-release capsules are a proton pump inhibitor


Venus Remedies expands ASEAN presence with new drug approvals in Vietnam
News | November 10, 2025

Venus Remedies expands ASEAN presence with new drug approvals in Vietnam

Venus Remedies now has 29 active product approvals in Vietnam alone


Glenmark secures China approval for Ryaltris
Drug Approval | November 10, 2025

Glenmark secures China approval for Ryaltris

The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline


Zydus Lifesciences secures FDA tentative approval for Olaparib tablets
Drug Approval | November 08, 2025

Zydus Lifesciences secures FDA tentative approval for Olaparib tablets

Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers


Alembic receives FDA final approval for Sumatriptan Injection USP
Drug Approval | November 08, 2025

Alembic receives FDA final approval for Sumatriptan Injection USP

Sumatriptan injection is indicated in adults for the acute treatment of migraine


Alembic announces USFDA final approval for Dasatinib Tablets
Drug Approval | November 08, 2025

Alembic announces USFDA final approval for Dasatinib Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets