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FDA approves a supplemental BLA for BioMarin Pharmaceutical Inc.’s Palynziq, expanding its use to adolescents 12 and older with PKU.

FDA expands approval of Novo Nordisk’s once-weekly Sogroya to include three new pediatric growth disorder indications, offering children as young as 2.5 an alternative to daily growth hormone injections backed by Phase III non-inferiority data.

RWD can bolster natural history studies with insight to longitudinal, real-time disease progression.

In today’s Pharmaceutical Executive Daily, the FDA approves Hernexeos under a national priority voucher program, industry leaders explore the expansion of direct-to-consumer HIV prevention strategies, and Dupixent gains FDA approval for allergic fungal rhinosinusitis.

FDA grants accelerated approval to Boehringer Ingelheim’s Hernexeos (zongertinib) for treatment-naïve HER2-mutant advanced NSCLC.

Joseph Kleiman examines how Trump Rx could pressure pharmacy benefit managers and retailers to increase transparency and affordability, while cautioning that its long-term impact will depend on price consistency.

Gilead’s VP of marketing and US HIV prevention discusses the new advertising campaign for Yeztugo.

The episode will explore structural implications for supply chains, distribution models, and international strategy—not a political discussion, but a forward-looking planning lens.

In today’s Pharmaceutical Executive Daily, Alkermes outlines its CEO succession plan following Richard Pops’ retirement announcement, leadership changes continue at Sarepta Therapeutics and Rivus Pharmaceuticals, and Boehringer Ingelheim secures an exclusive license for a preclinical small-molecule program.

Sarepta Therapeutics begins a CEO succession process, while Rivus Pharmaceuticals appoints a new chief executive to advance its late-stage pipeline in MASH, obesity, and cardiometabolic disease.

Alkermes announces that longtime CEO Richard Pops plans to step down on July 31, 2026, with his successor already set to step into the role on August 1.

Otsuka America’s president and CEO discusses being the first major pharma company to invest in psychedelics.

In the final part of his conversation with Pharmaceutical Executive, Sandy Donaldson discusses the challenges that pharma faces when marketing direct-to-consumers.