Regulatory

ADVI's Tyler Seville on how the IRA's drug pricing provisions are creating compliance burdens manufacturers can't meet without data they don't have.

ADVI's Tyler Seville on how 340B has become a financial liability for manufacturers while covered entities expand into wealthy suburban markets.

Why pricing pressure, policy volatility and supply-chain risk are pushing drugmakers toward greater cost and portfolio discipline, without losing sight of investment in innovation.

ADVI's Tyler Seville on how 340B grew from under $10 billion to over $100 billion annually — now larger than Medicaid and Medicare Part B.

Krieger Scientific’s founder and CEO discusses how various factors, such as siloed systems and misuse of AI, may be responsible for the increase of warning letters from FDA.

President Trump signs an executive order shrinking the recommended childhood vaccine schedule from 18 diseases to 11, and calls for the MMR shot to be split into three separate injections.

Krieger Scientific's Joseph Morwald on why well-positioned pharma companies treat the FDA as a partner, invest in unbiased third-party oversight, and continuously raise the bar on compliance rather than treating it as a fixed threshold to clear.

Krieger Scientific's Joseph Morwald on why unverified AI-generated documentation in pharma is a complex issue with potentially significant consequences.

FDA has granted accelerated approval to Replimune's Tudriqev plus nivolumab for anti-PD-1-refractory unresectable advanced cutaneous melanoma.

Krieger Scientific's Joseph Morwald explains how siloed departments, disconnected systems, and a lack of cross-functional accountability are creating the structural compliance gaps that FDA warning letters keep exposing.

Ron Lanton, senior partner at Lanton, Lanton & Sosa Law, discusses the legal risks associated with a hypothetical AstraZeneca–Bristol Myers Squibb merger.

FDA has approved Takeda's Orzeyful as the first oral orexin receptor 2 agonist for narcolepsy type 1 in adults.

The FDA has approved mFLUSIVA (mRNA-1010), Moderna's mRNA-based influenza vaccine, for use in adults 50 and older.

Krieger Scientific's Joseph Morwald on why over-reliance on AI and under-reliance on human expertise is driving the surge in FDA warning letters.

Recent changes at the U.S. Patent and Trademark Office are making it harder to challenge pharmaceutical patents, raising concerns that slower generic and biosimilar competition could undermine efforts to lower drug costs while strengthening protections for brand-name innovators.

Incubate’s executive director discusses China’s rise in biotech and why the US’ best response may be to focus on its own issues.

The Swiss generic drugmaker says the agreement carries no admission of wrongdoing and will not affect its 2026 guidance or mid-term outlook.

Incubate’s executive director discusses China’s rise in biotech and why the US’ best response may be to focus on its own issues.

FDA's advisory committee voted 10 to 3 that efficacy data from the Ignyte study is evaluable and clinically meaningful.

An FDA advisory panel voted to recommend six of seven unapproved peptides for compounding access, raising concerns about its newly appointed members.

FDA has approved Viatris' Gwyn Lo as a once-weekly low-dose estrogen contraceptive patch, offering women with a BMI below 30 a non-invasive hormonal contraception option.

Replimune shares fell nearly 32% after FDA staff reviewers raised concerns that its lead melanoma therapy RP1 lacks clear evidence of systemic efficacy.

In this episode, Ron Lanton argues that healthcare's next constraint isn't capital or technology but rather people.

TruTechnologies chairman and co-founder argues that while Operation TrialBlazer is directionally correct in targeting regulatory friction, it misses the larger problem.

FDA has approved Otsuka's Simtriyo as the first norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD.