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Results For "Astrazeneca"

344 News Found

India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters
Drug Approval | April 09, 2026

India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters

In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga


Lupin wins USFDA nod for generic Dapagliflozin tablets
Drug Approval | April 08, 2026

Lupin wins USFDA nod for generic Dapagliflozin tablets

Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market


Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity
Drug Approval | April 08, 2026

Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity

Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size


Aurobindo Pharma wins USFDA approval for generic Xigduo XR
Drug Approval | April 08, 2026

Aurobindo Pharma wins USFDA approval for generic Xigduo XR

Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually


Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity
Drug Approval | April 07, 2026

Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity

Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.


Investigational therapy efzimfotase alfa shows promising Phase III results in rare bone disease
Clinical Trials | April 01, 2026

Investigational therapy efzimfotase alfa shows promising Phase III results in rare bone disease

Efzimfotase alfa is an investigational enzyme replacement therapy designed to reduce injection volume


ENHERTU approved in China as first HER2-targeted ADC for early breast cancer
Drug Approval | March 31, 2026

ENHERTU approved in China as first HER2-targeted ADC for early breast cancer

The decision is based on the phase 3 DESTINY-Breast11 trial


India tackles rare diseases head-on at landmark summit in New Delhi
News | March 12, 2026

India tackles rare diseases head-on at landmark summit in New Delhi

Industry leaders highlighted the pharmaceutical sector’s role in advancing research, innovation, early screening, and multi-stakeholder collaboration


FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer
News | March 10, 2026

FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer

Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population


AIM ImmunoTech advances Phase 2 pancreatic cancer trial with Ampligen and Imfinzi
News | February 24, 2026

AIM ImmunoTech advances Phase 2 pancreatic cancer trial with Ampligen and Imfinzi

The study is a collaboration between AIM, AstraZeneca, and Erasmus Medical Center in the Netherlands