Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases

Glenmark secures China approval for Ryaltris

The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline

Marksans Pharma's Goa unit clears FDA inspection

The said inspection concluded with Zero Form 483 observation

Syngene International reports Q2 FY26 consolidated PAT at Rs. 67.1 Cr

Syngene International has reported total income of Rs. 926 crore during the period ended September 30, 2025

Alembic receives FDA final approval for Sumatriptan Injection USP

Sumatriptan injection is indicated in adults for the acute treatment of migraine

Alembic announces USFDA final approval for Dasatinib Tablets

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

Lupin Bioresearch Center receives zero observations from USFDA

A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations

Novo Nordisk’s new CEO doubles down on obesity, diabetes push despite mixed Q3

Sales from Novo’s GLP-1 portfolio—including Wegovy for obesity and Ozempic for type 2 diabetes reached $5.6 billion

Pfizer reports Q3 vaccine sales decline amid challenging US market conditions

Comirnaty, Pfizer’s COVID-19 prevention vaccine, reported global sales of $1.15 billion

Amgen confident in US biosimilar market’s strength as sales surge 52%