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FDA Approves Rhapsido® (Remibrutinib), the First Targeted Therapy for Symptomatic Dermographism
Symptomatic dermographism (SD) is a form of physical urticaria in which minor mechanical force, such as light scratching, friction from clothing, or stroking of the skin, induces localized erythema, pruritus, and wheal formation (1). SD is the most common subtype of chronic inducible urticaria (CIndU) seen in clinical dermatology and allergy practice. Together with chronic spontaneous urticaria (CSU), SD accounts for more than 90% of all chronic urticaria cases in adult popul

Dr. Manisha Dadlani
Oct 224 min read


Upcoming Medical Congresses
American College of surgeons - Clinical Congress 2026 Date of event: September 26–29,2026 Location: Washington, DC The conference provides a premier professional development forum for the global surgical community, bringing together renowned surgeons, researchers, and healthcare professionals to explore the latest advances in surgical science and clinical practice. Focused on translating groundbreaking research and innovative procedures into real-world patient care, the event

Ms. Vidya Kalyani
Sep 224 min read


FDA Approves Rusfertide, the First-in-Class Hepcidin Mimetic for Polycythemia Vera
Polycythemia vera is a chronic myeloproliferative neoplasm characterized by abnormal overproduction of red blood cells, resulting in erythrocytosis (1,2). This excess red blood cell production increases hematocrit, the proportion of red blood cells relative to total blood volume, thereby increasing blood viscosity. In the United States, PV affects an estimated 90,000 individuals (2). Elevated blood viscosity associated with uncontrolled hematocrit increases the risk of seriou

Dr. Manisha Dadlani
Sep 224 min read


FDA Approves Tirzepatide to Reduce Cardiovascular Risk in Adults with Type 2 Diabetes
Cardiovascular disease remains a major cause of morbidity and mortality among people with type 2 diabetes. Epidemiological studies estimate that as many as one in three U.S. adults with type 2 diabetes have undetected subclinical cardiovascular disease (1). David A. D’Alessio, Director of Endocrinology and Metabolism at Duke University School of Medicine, emphasized that “heart health deserves attention throughout the course of treatment, not just after a serious cardiovascul

Dr. Manisha Dadlani
Sep 224 min read


FDA Clears Libre Duo: The World’s First Dual Glucose & Ketone Monitor
In India, around 77 million people aged 18 and above are suffering from type 2 diabetes. Another alarming fact is that around 25 million are prediabetic, as of a recent report, and are at higher risk of developing diabetes in the near future. More than 50% are unaware of their diabetes status (1). Diabetic ketoacidosis (DKA) remains an important acute complication of diabetes in India, occurring predominantly in people with type 1 diabetes but also affecting those with type 2

Dr. Manisha Dadlani
Sep 215 min read


FDA Approves First in Class FcRn Blocker IMAAVY (Nipocalimab aahu) for Warm Autoimmune Hemolytic Anemia
On August 24, 2026, the U.S. Food and Drug Administration approved Janssen Biotech’s IMAAVY (nipocalimab-aahu) injection for adult and pediatric patients aged 12 years and older currently or previously treated with corticosteroids (1,2). This landmark decision represents the first therapy proven safe and effective specifically for warm autoimmune hemolytic anaemia (wAIHA). As a first-in-class treatment, IMAAVY offers clinical management for an underserved community that has h

Dr. Manisha Dadlani
Sep 155 min read


Daraxonrasib: Restoring Hope in Pancreatic Cancer Management
Pancreatic ductal adenocarcinoma (PDAC) remains one of the most difficult challenges in modern oncology. It is a condition characterised by aggressive tumour growth and a high mortality rate, with a five-year survival rate that persists below 13% (1). Because the disease is often asymptomatic in its early stages, the majority of patients are diagnosed only after the cancer has become metastatic and unresectable. While this mutation drives the disease, the RAS protein was long

Dr. Manisha Dadlani
Aug 316 min read


FDA Grants Accelerated Approval to Sevabertinib for Advanced HER2-Mutant Non-Squamous NSCLC
Non small cell lung cancer (NSCLC) is the most common form of lung cancer and remains a leading cause of cancer related mortality worldwide. Activating HER2 mutations occur in approximately 2% to 4% of advanced NSCLC cases, defining a distinct molecular subgroup that frequently affects individuals who have never smoked. Patients with HER2 mutant NSCLC typically face a poor clinical prognosis and, until recently, have had limited targeted treatment options (1). Unmet Needs in

Dr. Manisha Dadlani
Aug 304 min read


FDA Approves Lipfendra (enlicitide), the First Oral PCSK9 Inhibitor for LDL-C Reduction
Hypercholesterolemia occurs when blood levels of low-density lipoprotein cholesterol (LDL-C) are elevated (1). High LDL-C is a major modifiable risk factor for atherosclerotic cardiovascular disease (ASCVD), which remains a leading cause of mortality worldwide and in the United States (1,2). Excess circulating LDL-C progressively deposits within arterial walls, accelerating plaque formation, narrowing vessels, and restricting blood flow. Plaque rupture can precipitate thrombo

Dr. Manisha Dadlani
Aug 285 min read


FDA approves Roctavian gene therapy for severe Haemophilia A
Halfway through the year 2023, BioMarin bagged the approval for an “adeno-associated virus serotype 5 (AAV5)” gene therapy by the United States Food and Drug Administration (FDA). The therapy is for adults with a life-threatening and rare genetic condition known as Haemophilia A. In this article we will discuss about the novel therapy and the studies leading to its approval. Haemophilia A, also referred to as an X-linked disorder affects 1 in 5,000 male births. The sex-linke

Ms. Pragya Agarwal
Sep 10, 20254 min read


U.S. FDA approves low dose Colchicine for ASCVD risk reduction
Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of morbidity and mortality worldwide, affecting over 500 million individuals globally and resulting in approximately 19 million deaths annually. It is caused by the build-up of plaque that leads to hardening of the arteries. It can limit blood flow through the arteries which can result in severe conditions such as coronary heart disease, stroke, angina, or peripheral artery disease. The control of traditional c

Dr. Uttara Shankar
Sep 10, 20254 min read


Afrezza® inhaled insulin is approved for diabetes management
In the 2nd week of December 2024, the medical fraternity received a piece of heart-warming news about inhaled insulin. Cipla received approval for the distribution and marketing of Afrezza® an inhaled insulin in India. The product created by Mannkind Corporation can be a blessing for millions of Indians who have compliance issues with injectable insulin (1). About Afrezza® Afrezza® (inhalable insulin) is a promising, ultra-rapid-acting noninjectable insulin delivery option de

Dr. Sheeba Rani
Sep 9, 20254 min read


FDA approves blood test for the diagnosis of Alzheimer’s Disease
Alzheimer’s disease is a progressive neurodegenerative disorder that affects the brain, gradually impairing memory, reasoning, and behaviour. The disease is marked by the accumulation of abnormal protein deposits in the brain, specifically amyloid plaques and tau tangles. These deposits disrupt neural function and ultimately lead to brain cell death. Over time, individuals lose the ability to carry out daily tasks and experience significant personality and behavioural changes

Ms. Hima Saxena
Sep 9, 20254 min read


US FDA approves Lenacapavir for HIV prevention
According to recent estimates, there are around 2.14 million HIV cases in India. Around 83% of these are in the age group 15-49 years (1). Antiretroviral therapy is the common treatment strategy followed which involves taking a combination of HIV medicines daily, monthly, or every other month. Although there is no cure for HIV, prompt treatment can help HIV patients live a healthy life and reduce the risk of transmission (2). On June 18th, 2025, the USFDA approved Gilead's Y

Ms. Roma Joglekar
Sep 8, 20252 min read
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