Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 86

Results For "ANDA"

2595 News Found

Calquence combination approved in US for untreated mantle cell lymphoma
Drug Approval | January 18, 2025

Calquence combination approved in US for untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone


AstraZeneca receives CDSCO approval to launch eculizumab in India
Drug Approval | January 17, 2025

AstraZeneca receives CDSCO approval to launch eculizumab in India

Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome


Alembic announces USFDA final approval for Brexpiprazole Tablets
Drug Approval | January 16, 2025

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


Odisha to implement AB PM-JAY scheme
News | January 14, 2025

Odisha to implement AB PM-JAY scheme

The scheme is fully digitized and covers approximately 45% of India's population


USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Drug Approval | January 13, 2025

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance


Pfizer’s Sasanlimab in combination with BCG improves survival in patients with bladder cancer
Clinical Trials | January 13, 2025

Pfizer’s Sasanlimab in combination with BCG improves survival in patients with bladder cancer

If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population


Iconovo and Lonza to collaborate on formulation development of an intranasal biologic
News | January 13, 2025

Iconovo and Lonza to collaborate on formulation development of an intranasal biologic

Lonza to develop spray-dried formulations for an intranasally-delivered biologic for Iconovo at its Center of Excellence for bioavailability enhancement and inhaled delivery in Bend (US)


ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe
News | January 10, 2025

ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe

According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually