Regulatory

FDA has granted accelerated approval to Zenbexus plus daratumumab and Hyaluronidase-fihj and dexamethasone for multiple myeloma after at least one prior line of therapy.

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.

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.

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

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.

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.

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

Incubate’s executive director John Stanford defines the three buckets of the US-China pharma challenge: API manufacturing, clinical trial competitiveness, and the complex ethics of licensing Chinese innovation.

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.

John Stanford, executive director at Incubate, discusses how China's two decades of biotech investment are paying off.

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.

TruTechnologies’ Dr. Richard Graham explains where he sees the actual issues that need to be addressed at FDA.

An FDA advisory panel voted narrowly to recommend four unapproved peptides, BPC-157, KPV, TB-500, and MOTS-c.

Dr. Richard Graham, chairman and co-founder of TruTechnologies, discusses the importance of global clinical trials while also being a center for these trials.

In today's Pharmaceutical Executive Daily, Eli Lilly's Retatrutide delivers up to 22.6% weight loss in two new Phase III trials, a clinical trial expert discusses why the U.S. is losing trial volume to Australia and China, and a pharmacy benefits executive weighs in on why short-term cost thinking is complicating GLP-1 coverage decisions.

TruTechnologies’ chairman and co-founder Dr. Richard Graham explains why Australia and China are the main competitors for clinical trials.