PharmExec

Pharmaceutical Executive Daily: FDA Plans to Remove Two Study Requirement for New Drug Approvals

In today’s Pharmaceutical Executive Daily, the FDA reportedly removes its two-study requirement for new drug approvals, Hims ...
PharmExec

Hims & Hers Enters $1.15 Billion Agreement to Acquire Eucalyptus

Eucalyptus brings >775,000 customers, multi-country operating presence, >20 peer-reviewed studies on outcomes/adherence/safety, and Australian Council on Healthcare Standards accreditation. Tim Doyle ...
PharmExec

From Launch to Loss of Exclusivity: Reducing Access and Affordability Barriers Across the Brand Lifecycle

Discover how access barriers evolve across the biopharma brand lifecycle, from launch to loss of exclusivity, and how to address them proactively. Learn how data-driven insights and affordability ...
PharmExec

ACIP February Meeting Cancelled: Report

ACIP vice chair has even publicly accused FDA Commissioner Marty Makary of blocking or stalling efforts to pull the vaccines off the market. According to reports from that time period, ACIP members ...
PharmExec

Eli Lilly Announces Positive Results for Treating Crohn’s Disease with Omvoh

Crohn’s patients taking Omvoh saw three-years of remission when taking Omvoh, according to new long-term data released by Eli Lilly. 1 The data is the result of the Phase 3 VIVID-2 open label ...
PharmExec

FDA Removes Two Study Requirement for New Drug Approval Process: Report

FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...
PharmExec

Eli Lilly Enters $100 Million Licensing Agreement with CSL Limited for Clazakizumab

Exclusive licensing grants Lilly development and commercialization rights for clazakizumab beyond ESKD-related cardiovascular prevention, while CSL retains the ESKD cardiovascular events indication.
PharmExec

FDA Initiating Review of Moderna’s Seasonal Flu Vaccine Following Revised Regulatory Approach

On the heels of a Type A meeting with FDA’s Center for Biologics and Research (CBER), Moderna’s seasonal influenza vaccine ...
PharmExec

From Sun Belt Boom to Biotech Hub: Why Southern Florida’s Moment has Arrived

The broader Miami-Fort Lauderdale-West Palm Beach metro produced $533.7 billion in GDP in 2023, a nearly 9% year-over-year ...
PharmExec

Pharmaceutical Executive Daily: FDA Approves New Dosing Schedule for Rybrevant Faspro

In today’s Pharmaceutical Executive Daily, the FDA approves a monthly dosing schedule for Rybrevant Faspro, HHS Secretary ...
PharmExec

You Can Just (Not) Do Stuff: FDA’s Power to De-Bottleneck Early-Stage Clinical Trials

What’s been overlooked is that the FDA already has the power to fix this. Without new legislation, pilot programs, or years ...
PharmExec

Pharmaceutical Executive Daily: FDA Initiates Review of Moderna’s Seasonal Influenza Vaccine

In today’s Pharmaceutical Executive Daily, the FDA begins reviewing Moderna’s seasonal flu vaccine under a revised regulatory approach, Eli Lilly signs a $100 million licensing agreement with CSL for ...