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Lupin’s Ankleshwar facility receives EIR from U.S. FDA
Drug Approval | May 28, 2026

Lupin’s Ankleshwar facility receives EIR from U.S. FDA

The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026


Alembic Pharma receives USFDA nod for generic Levothyroxine sodium tablets
Drug Approval | May 22, 2026

Alembic Pharma receives USFDA nod for generic Levothyroxine sodium tablets

Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism


Lupin gets tentative FDA nod for Revefenacin inhalation solution
Drug Approval | May 20, 2026

Lupin gets tentative FDA nod for Revefenacin inhalation solution

The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)


FDA expands Enhertu use in early HER2-positive breast cancer
Drug Approval | May 19, 2026

FDA expands Enhertu use in early HER2-positive breast cancer

AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease


Caplin Steriles receives USFDA approval for generic foscarnet sodium injection
Drug Approval | May 18, 2026

Caplin Steriles receives USFDA approval for generic foscarnet sodium injection

Antiviral injection addressing CMV and HSV infections had US market sales of nearly $15 million in the last 12 months


Lupin receives USFDA nod for Famotidine injection
Drug Approval | May 15, 2026

Lupin receives USFDA nod for Famotidine injection

Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market


Alembic Pharma receives USFDA tentative approval for Darolutamide tablets
Drug Approval | May 15, 2026

Alembic Pharma receives USFDA tentative approval for Darolutamide tablets

Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States


FDA okays RIVANNA’s AI-powered Accuro XV ultrasound system
Medical Device | May 12, 2026

FDA okays RIVANNA’s AI-powered Accuro XV ultrasound system

The clearance marks a pivotal step forward for the company as it pushes deeper into AI-driven diagnostics and expands its clinical footprint in point-of-care imaging