FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...
Exclusive licensing grants Lilly development and commercialization rights for clazakizumab beyond ESKD-related cardiovascular prevention, while CSL retains the ESKD cardiovascular events indication.
The broader Miami-Fort Lauderdale-West Palm Beach metro produced $533.7 billion in GDP in 2023, a nearly 9% year-over-year ...
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 ...
On the heels of a Type A meeting with FDA’s Center for Biologics and Research (CBER), Moderna’s seasonal influenza vaccine ...
In today’s Pharmaceutical Executive Daily, the FDA approves a monthly dosing schedule for Rybrevant Faspro, HHS Secretary ...
What’s been overlooked is that the FDA already has the power to fix this. Without new legislation, pilot programs, or years ...
In today’s Pharmaceutical Executive Daily, the FDA issues a Complete Response Letter for Disc Medicine’s bitopertin in EPP, ...
HHS Secretary Robert F. Kennedy Jr. reorganized senior leadership at the department to streamline management and advance the administration’s health policy priorities.
Scaling without losing local relevance requires humility, trust, and a willingness to relinquish the illusion that control ...
Pharm Exec’s 21st Annual Pipeline Report examines emerging drug development classes, treatment modalities, and expansion ...
FDA approved a simplified, once-monthly dosing schedule for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) when used in combination with Lazcluze (lazertinib) as a first-line treatment for ...
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