
Regulatory
Latest Content

Pharmaceutical Executive Daily: Nxera Licenses EP4 Agonist to AbbVie

The Promise of Microgravity for R&D and Manufacturing

Roundup: Boehringer Ingelheim Licenses Six Oncology Programs From Sino Biopharmaceutical, Nxera Licenses EP4 Agonist to AbbVie

How Tumors Change Over Time, and How This Impacts Treatment

Why Leronlimab Isn’t Just Another Repurposed Drug: Q&A with Dr. Jay Lalezari

Shorts









Podcasts
Videos
All News

Lonza will add bioconjugate, payload-linker and viral vector capacity and about 1,100 employees; closing is expected in mid-2027.

Novartis exits its BrainTransporter deal with BioArctic 14 months after signing, citing an internal portfolio decision unrelated to the platform.

Teva will gain U.S. rights to two approved Samsung Bioepis biosimilars in a profit-sharing deal expected to close by the end of 2026.

Karyopharm filed for Chapter 11 under a plan to merge with Ayrmid, with competing bids allowed and closing targeted for the first quarter of 2027.

Dr. Jay Lalezari of CytoDyn explains why Leronlimab’s circulating tumor DNA results in colorectal cancer represent a unique, mechanism-specific proof of concept rather than a broader template.

FDA grants accelerated approval to INOVIO’s Voceryq to reduce surgical burden in recurrent respiratory papillomatosis, Brox.AI’s Hamish Brocklebank on the three levels of digital clone use cases in pharma, and CytoDyn’s Dr. Jay Lalezari on his path from HIV clinician to CEO.

PhRMA's Scott LaGanga discusses the expanding influence of state policymaking on drug pricing, PBM reform, and efforts to translate policy changes into lower out-of-pocket costs for patients.

FDA grants accelerated approval to INOVIO’s Voceryq for reducing surgery frequency in adults with recurrent respiratory papillomatosis.

Dr. Jay Lalezari, CytoDyn’s CEO and CMO, discusses his path from HIV clinician to drug developer.

Sun Pharma's IL-23 inhibitor tildrakizumab gains a psoriatic arthritis indication; the announcement cited no phase 3 efficacy figures.

Brox.AI's co-founder and CEO on why telling an AI to pretend to be a doctor isn’t the same as cloning one — and why that distinction matters for pharma.

Shionogi’s Dr. Draica on why mild COVID-19 still matters, how XOCOVA blocks replication before symptoms, and why prevention beats treatment.

Earlier pediatric planning, innovative trial design, and closer collaboration among regulators, industry, and families are needed to close the persistent gap between the evidence available for adult and pediatric treatments.

BioMarin licenses long-acting Fabry enzyme replacement therapy HM15421/GC1134A, while Ferring agrees to acquire fertility biotech Gameto.

As AI accelerates drug discovery, the industry’s next challenge is building a connected, standards-based data infrastructure capable of supporting it through clinical development.


























