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2439 News Found

NATCO Pharma receives USFDA approval for Lenalidomide capsules
Policy | May 24, 2021

NATCO Pharma receives USFDA approval for Lenalidomide capsules

NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.


Alembic gets USFDA approval for Lurasidone Hydrochloride tablets
News | May 15, 2021

Alembic gets USFDA approval for Lurasidone Hydrochloride tablets

Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder


Alembic announces USFDA approval for two drugs
News | May 06, 2021

Alembic announces USFDA approval for two drugs

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA


Caplin Steriles gets USFDA approval
News | April 23, 2021

Caplin Steriles gets USFDA approval

The injection comes in multiple formats


Zydus Cadila announces USFDA approval for Ibrutinib capsules
News | April 08, 2021

Zydus Cadila announces USFDA approval for Ibrutinib capsules

Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.


Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets
News | February 25, 2021

Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets

ranules now has a total of 38 ANDA approvals from US FDA.


USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis
News | February 24, 2021

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis

The company will review FDA's response and decide on appropriate next steps soon.


Zydus Cadila receives final approval from USFDA for Droxidopa capsules
News | February 20, 2021

Zydus Cadila receives final approval from USFDA for Droxidopa capsules

It is used to treat low blood pressure that causes severe dizziness or a lightheaded feeling.


Lilly posts strong early clinical results for one-shot gene-editing cholesterol therapy
Clinical Trials | May 26, 2026

Lilly posts strong early clinical results for one-shot gene-editing cholesterol therapy

A one-shot gene-editing cholesterol therapy could soon be a reality


Datroway wins US nod in aggressive breast cancer subtype
Drug Approval | May 25, 2026

Datroway wins US nod in aggressive breast cancer subtype

Clearance marks major shift beyond chemotherapy