Regulatory
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Oct 09, 2025 | News
FDA Approves Libtayo for Immunotherapy for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma
Novo Nordisk Enters $4.7 Billion Definitive Agreement with Akero Therapeutics
Oct 09, 2025
Challenges of Positioning an Ultra-Sensitive Platform
Oct 09, 2025
Pharmaceutical Executive Daily: Amgen Launches New Direct-To-Consumer Platform
Oct 08, 2025
FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis Treatment
Oct 08, 2025
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Regulatory Uncertainty
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Obesity Medication's Unique Marketing Environment
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Paul Hudson: A Mindset for Miracles
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Pharmaceutical Executive: September 2025 Issue (PDF)
Click the title above for a link to open the Pharmaceutical Executive September 2025 issue in an interactive PDF format.
Coaching Flag Football—And Guiding a Biotech Through Commercialization
Useful tips and parallels for staying in the game following a complete response letter.
From Lab to Market: Tracking Today’s Shifting Pathways for Biotech
Outlining the key touchpoints for embracing change and opportunity in the “messy, tough—and fun” R&D-to-commercial transition journey.
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Johnson & Johnson's Simponi gains FDA approval for treating pediatric ulcerative colitis, expanding options for young patients with this chronic condition.
Shana Tetrault, PhD, Director of Product Marketing at Quanterix, discussed translating complex scientific findings into actionable insights for healthcare providers and stakeholders, emphasizing the importance of early disease detection.
In today’s Pharmaceutical Executive Daily, we cover the FDA lifting its clinical hold on Neurizon Therapeutics’ lead program Nuz-001, the agency’s export ban on Sun Pharma’s Halol facility, and new insights on how small biotechs can better navigate regulatory and market complexities.
Algen Biotechnologies partners with AstraZeneca to enhance AI-driven drug discovery, targeting chronic inflammatory conditions for innovative therapeutic solutions.
Chiesi Group partners with Arbor Biotechnologies to advance gene editing therapies for rare diseases, focusing on primary hyperoxaluria type 1.
Amgen introduces AmgenNow, a direct-to-patient program for Repatha, offering affordable access to life-saving cardiovascular treatment.
Stay informed on key pharmaceutical news, including FDA insights, Takeda's strategic shifts, and updated CDC COVID-19 vaccination guidelines.
CDC introduces shared-decision making for COVID-19 vaccinations, emphasizing informed consent and individual consultation with healthcare providers.
Neurizon Therapeutics advances ALS treatment as FDA lifts clinical hold on NUZ-001, paving the way for Phase II and III trials.
Dr. Jeanne Marrazzo's firing highlights concerns over political interference in health research and vaccine safety advocacy amid whistleblower allegations.
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In today’s Pharmaceutical Executive Daily, we cover the FDA’s new fast-track review program for U.S.-made generics, Novartis’ FDA approval of Rhapsido for chronic spontaneous urticaria, and Halozyme’s $750 million acquisition of Elektrofi to strengthen drug delivery innovation.
Products tested and manufactured exclusively from domestic materials will be eligible for the program.
Roche's Tecentriq and lurbinectedin combo gains FDA approval, significantly improving outcomes for extensive-stage small cell lung cancer patients.
Jazz Pharmaceuticals announces FDA approval of Zepzelca and Atezolizumab for extensive-stage small cell lung cancer, enhancing treatment options and survival rates.
Stay informed on key pharmaceutical news, including tariff updates, FDA shutdown risks, and insights from recent cell and gene therapy reviews.
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