Merck’s experimental cancer drug wins FDA breakthrough status in key lung cancer setting

The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial

Glenmark posts strong FY26 results with 27.5% revenue jump

Lupin wins FDA nod for generic colonoscopy prep drug with first-to-file exclusivity

Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market

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

Abbott secures CE mark for first dual glucose-ketone monitoring systems

Libre Duo devices become the first glucose-ketone monitors approved for diabetes care, offering real-time alerts for diabetic ketoacidosis risk

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

Quotient Sciences advances AI-designed drug product into Phase I clinical study

Company launches clinical study of AI-designed oral formulation following MHRA approval, marking a major milestone in AI-driven drug development.