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

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 announces USFDA final approval for Dasatinib Tablets

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

Zydus Lifesciences secures FDA tentative approval for Olaparib tablets

Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers

Alembic receives FDA final approval for Sumatriptan Injection USP

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

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

AstraZeneca invests additional $136 million to expand Qingdao inhalants facility

This latest commitment brings the British pharmaceutical company’s total investment at the site to $886 million

MSD secures $700 million boost from Blackstone to advance broad-cancer ADC therapy Sac-TMT

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