
Regulatory
Latest Content

Eli Lilly and Abbisko Announce Drug Development Collaboration

How 3D Printing Speeds Up Drug Production

The Economics of the 340B Drug Pricing Program: Strategic Imperatives for the Life Sciences Industry in 2026

Pharmaceutical Executive Daily: FDA Pilot Targets Faster Early-Stage Drug Trial Starts

The Next Evolution of Class of Trade: Why Customer Identity Is Becoming Market Access’s Hardest Problem

Shorts










Podcasts
Videos
All News

FDA plans a pilot to shorten early-stage drug trial timelines, raising strategic questions for biopharma development and investment.

Kyle Smith, president and COO of Aprecia, explains how the EQUIP-A-Pharma program is promoting the reshoring of pharma and biotech manufacturing.

Clinical Affairs supports responsible promotion through scientific validation, cross-functional collaboration, and oversight of both traditional and digital communications.

In today's Pharmaceutical Executive Daily, AbbVie announces a $10.9 billion agreement to acquire Apogee Therapeutics, adding a suite of clinical-stage immunology assets to its portfolio, Insilico Medicine enters an AI-powered drug discovery collaboration with SK Biopharmaceuticals valued at up to $2.5 billion to advance neuroimmune treatments in the central nervous system, and Pharmaceutical Executive speaks with Kyle Smith, president and COO of Aprecia Pharmaceuticals, on the real-world benefits and persistent challenges of operating as a fully domestic manufacturer in an era of tariffs and supply chain pressure.

Insilico will use its AI platform for the drug development process, while SK handles the late-stage and commercialization processes.

The acquisition will bolster AbbVie’s pipeline, including the addition of monoclonal antibody treatment zumilokibart.

Aprecia’s president and COO Kyle Smith explains the challenges domestic manufacturers face when sourcing certain API and materials.

In today's Pharmaceutical Executive Daily, an FDA advisory committee votes unanimously in favor of the benefit-risk profile of Moderna's investigational mRNA-1010 seasonal influenza vaccine across both younger and older adult populations, a pharma funding roundup covers Kardigan's upsized $400 million IPO debut on Nasdaq and cAMPfield Therapeutics' $180 million Series A launch, and Pharmaceutical Executive speaks with Brian Hilberdink of Boehringer Ingelheim on redefining what success looks like in obesity care in the GLP-1 era.

Kardigan priced its cardiovascular IPO at $400 million and surged 31% on its Nasdaq debut, while cAMPfield Therapeutics launched the same week with a $180 million Series A to advance prifemilast.

FDA advisory panel voted 9-0 to recommend approval of Moderna's mRNA flu vaccine mRNA-1010 across both the 50-to-64 and 65-and-older age groups, a unanimous outcome that validates the underlying clinical data.

Kyle Smith, president and COO of Aprecia, discusses how additive manufacturing allows for the rapid development and manufacturing of a variety of dosage forms.

As GLP-1 therapies reshape obesity care, Brian Hilberdink, president of U.S. Human Pharma, Boehringer Ingelheim, argues that lasting progress depends on targeting metabolic health, not just the number on the scale.

In today's Pharmaceutical Executive Daily, Biogen announces its second acquisition of 2026, a deal worth up to $1 billion for private immunology biotech RayThera, FDA approves Utebzi as the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections, and FDA expands the indication for Merck's Capvaxive to include children and adolescents aged 2 through 17 with chronic medical conditions at increased risk for pneumococcal disease.

FDA has expanded Capvaxive's indication to high-risk children and adolescents aged 2 through 17 who have completed a primary pneumococcal series, making it the only conjugate vaccine in the U.S. specifically studied and approved for this population.

FDA has approved Utebzi as the first oral carbapenem antibiotic for complicated urinary tract infections, giving patients and providers an alternative to intravenous-only carbapenem therapy.























