
Regulatory
about 15 hours ago
FDA Expands Enhertu in Early HER2-Positive Breast Cancerabout 18 hours ago
FDA’s New Pilot Program and Real-Time Review of Clinical Dataabout 18 hours ago
How Pharma is Adjusting Strategies for Changing Dynamics at FDALatest Content

Pharmaceutical Executive Daily: FDA Approves Baxdrostat

FDA Makes Leadership Overhaul Following Commissioner Makary’s Departure: Report

FDA Approves Baxdrostat for Uncontrolled Hypertension in First-in-Class Entry

Regeneron Enters $2.3 Billion Collaboration with Parabilis Medicines to Discover & Develop Multiple Therapeutic Candidates

FDA Expands Enhertu in Early HER2-Positive Breast Cancer

Shorts









Podcasts
Videos
All News

Toragen’s partnership with the Bill & Melinda Gates Foundation highlights how global health priorities and commercial biotech strategy can align around one of the world’s deadliest HPV-driven cancers.

Dr. Richard Graham explains how FDA’s new program allows for the usage of real-time data during clinical trials.

Author Jeremy Levin discusses how various factors are impacting the biotech industry in a negative way by pushing investment and politics over science.

David Crean, chief business officer at MedicNova, discusses changes at FDA causing variability and unpredictability in regulatory approvals.

In today's Pharmaceutical Executive Daily, FDA approves AstraZeneca's Fasenra as a new treatment for hypereosinophilic syndrome in patients 12 years and older, the FDA places a full clinical hold on Aardvark Therapeutics' ARD-101 program, and BeOne Medicines co-founder and CEO John Oyler touches on building an oncology powerhouse from a disruptive idea and playing the long game on speed, science, and scale.

BeOne Medicines’ John Oyler on building an oncology pharma power from a disruptive idea — and playing the long game on speed, science and scale.

FDA places full clinical hold on Aardvark’s ARD-101 in Prader-Willi syndrome after heart-related adverse events, pausing late-stage studies and raising new questions around safety in appetite-regulation therapies

FDA approved AstraZeneca’s Fasenra for hypereosinophilic syndrome in patients aged 12 and older, expanding the IL-5 receptor-targeting therapy into a third eosinophil-driven disease with limited treatment options.

Dr. Jeremy Levin discusses the mismatch between capital markets and biotech and how the industry doesn’t provide the results that investors are often looking for.

Toragen CEO, Sandra Coufal, MD, says women’s health remains structurally underfunded, arguing that outdated market assumptions continue to undervalue the true commercial opportunity in HPV-driven cancers.

In today's Pharmaceutical Executive Daily, the FDA grants accelerated approval to BeOne Medicines' Beqalzi as the first and only BCL2 inhibitor for relapsed or refractory mantle cell lymphoma, while also approving Taiho Oncology's Inqovi in combination with venetoclax for newly diagnosed acute myeloid leukemia, Pharmaceutical Executive reports on the Doceree Makers Summit, and Dean Erhardt argues that AI-enabled workflow automation offers a practical path to fixing the prior authorization system's chronic failures.

Trialynx’s CEO discusses the benefits of using AI for trial design and how to find the AI companies doing the most promising work.

At the Doceree Makers Summit, leaders from Sanofi, Bristol Myers Squibb, Eli Lilly, and others backed a new pharma marketing operating model to replace fragmented legacy softwares.

How existing technologies and approaches such as targeted AI deployment can help make prior authorization workflows more efficient.

FDA has approved BeOne Medicines’ Beqalzi for relapsed or refractory mantle cell lymphoma and Taiho Oncology’s Inqovi plus venetoclax for newly diagnosed acute myeloid leukemia, expanding treatment options for patients with difficult-to-treat blood cancers.

























