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9 News Found

US & UK reach historic pharma pricing pact
Policy | December 03, 2025

US & UK reach historic pharma pricing pact

The deal aims to address long-standing imbalances in pharmaceutical trade while boosting investment and innovation on both sides of the Atlantic


Hormone therapy for menopause gets green light from FDA
News | November 14, 2025

Hormone therapy for menopause gets green light from FDA

The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature


FDA launches crackdown on deceptive drug advertising
Policy | September 16, 2025

FDA launches crackdown on deceptive drug advertising

The FDA is beginning rulemaking to close the “adequate provision” loophole


argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG
News | August 28, 2025

argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG

VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications


FDA restrict 7-OH opioid products to protect consumers
News | August 03, 2025

FDA restrict 7-OH opioid products to protect consumers

7-OH is a concentrated byproduct of the kratom plant and has shown potential for abuse by binding to opioid receptors


EIP Pharma and Diffusion Pharmaceuticals inks agreement to create CNS-focused company
News | April 03, 2023

EIP Pharma and Diffusion Pharmaceuticals inks agreement to create CNS-focused company

EIP Pharma to initiate in 2Q 2023 a Phase 2b clinical study, funded in part by a $21 million grant from the National Institute of Aging


Merck to acquire Imago BioSciences for $1.35 bn
News | November 22, 2022

Merck to acquire Imago BioSciences for $1.35 bn

Acquisition expands Merck’s growing hematology portfolio


WuXi STA breaks ground for second manufacturing facility in US
News | August 19, 2022

WuXi STA breaks ground for second manufacturing facility in US

This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region


Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD