FDA greenlights AstraZeneca’s Imfinzi combo in bladder cancer breakthrough

The study tracked patients for more than five years (median 60.7 months), with protection against disease returning emerging in under four months and continuing long term

FDA delays AstraZeneca decision on camizestrant as regulators seek more data

The filing is backed by results from the pivotal SERENA-6 Phase III trial

Lupin secures FDA nod for generic Sutab tablets with 180-day exclusivity

The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals

AbbVie wins FDA nod for DECNUPAZ in rare blood cancer

BPDCN typically presents with skin lesions before rapidly spreading to the bone marrow, lymph nodes

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

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

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

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

FDA grants accelerated approval to BEQALZI for relapsed mantle cell lymphoma

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