The Pipeline Blog
In The Pipeline Blog, we aim to discuss a variety of medical and regulatory affairs topics.
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Securing the Drug Supply Chain in the AI Era: From Compliance to Predictive Resilience
Writer: Mohona Sarkar Drug shortages create disruptions in treatment plans, potentially causing life-threatening situations for the patient or the public during an epidemic or outbreak. For years, they were treated as temporary interruptions that were inconvenient, but manageable. That assumption … Read more
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Opening the Barrier: Focused Ultrasound for Improved Brain Drug Delivery
Writer: Julia Lanfersieck Editor: Emily DiMaulo-Milk Diseases of the brain are often among the most challenging to treat. This is in large part because of the blood-brain barrier (BBB), a protective layer which restricts the passage of substances from the … Read more
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Optune Pax to treat locally advanced pancreatic cancer
Author: Grace Stroman Editor: Meghan Diefenbacher Today’s article will discuss the Food and Drug Administration (FDA) approval of Optune Pax® for pancreatic cancer as a result of the PANOVA-3 study. On February 11th, 2026, Optune Pax in combination with gemcitabine … Read more
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Part 2: Targeting a common virus to treat Multiple Sclerosis (MS)? The efforts to develop a vaccine against Epstein-Barr Virus (EBV)
Writer: Emily DiMaulo-Milk Editor: Joe Krzeski In April 2025, Moderna initiated a Phase II Clinical trial testing the investigational vaccine mRNA-1195 in patients with MS.1 This vaccine targets the common virus, Epstein-Barr Virus (EBV), which causes “mono”.2 A detailed explanation of the … Read more
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An overview: Menopause and LYNKUET for the treatment of vasomotor symptoms
Author: Tiffany Peters Editor: Joe Krzeski Menopause and its associated symptoms The definition of menopause has evolved over the past 20 years. Menopause has been defined as the moment one year after menstrual flow has stopped [1]. It can also … Read more
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Sohonos for the Treatment of Fibrodysplasia Ossificans Progressiva
Author: Caryssa Drinkuth Editor: Meghan Diefenbacher Overview of Fibrodysplasia Ossificans Progressiva (FOP): Fibrodysplasia ossificans progressiva (FOP) is an ultra-rare, debilitating genetic disorder that affects an estimated 1 in 1.14 million people living in the United States.1 FOP is characterized by heterotopic … Read more
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Part 1: Targeting a common virus to treat Multiple Sclerosis (MS)? Explaining the evidence for a link between Epstein-Barr Virus and MS.
Writer: Emily DiMaulo-Milk Editor: Caryssa Drinkuth In April 2025, Moderna initiated a Phase II Clinical trial testing the investigational vaccine mRNA-1195 in patients with MS.1 This vaccine targets the common virus, Epstein-Barr Virus (EBV), most well-known as the virus which causes … Read more
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FDA Approves Proliv™Rx: A Milestone for At-Home Neuromodulation in Depression Care
Writer: Kaitlin Kinney Editor: Sarah Sizer Major depressive disorder (MDD) remains one of the most common and disabling mental health conditions worldwide, with an estimated 332 million people affected globally.1,2 While antidepressant medications and psychotherapy are effective for many individuals with … Read more
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CD388: A Novel Long-Acting and Broadly Protective Antiviral for the Treatment and Prevention of Influenza Virus Infections
Writer: Meghan Diefenbacher Editor: Pari Dhayagude The influenza virus is a respiratory pathogen that remains a significant global public health burden. Seasonal epidemics of influenza cause approximately 3-5 million cases of severe illness and 290,000-650,000 respiratory deaths worldwide.1 Although the … Read more
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Durvalumab immunotherapy approved for gastric or gastroesophageal junction adenocarcinoma
Author: Grace Stroman Editor: Tiffany Ko Today’s article will discuss the Food and Drug Administration (FDA) approval of durvalumab for gastric (GC) and gastroesophageal junction adenocarcinoma (GEJC) as a result of the multinational MATTERHORN study. On November 25th, 2025 durvalumab … Read more