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Beyond Air, Inc. (NASDAQ: XAIR) has submitted a premarket approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for its second-generation LungFit PH II system....

The U.S. Food and Drug Administration (FDA) has approved BRINSUPRI™ (brensocatib), making it the first and only therapy for non-cystic fibrosis bronchiectasis (NCFB). . This chronic lung disease affects more than 500,000 people in the United States and has long been without an approved treatment option....

Cell and gene therapies (CGTs) represent a new frontier in healthcare. These treatments aim to modify or replace cells and genes to treat or cure diseases that were previously untreatable. . While their promise is enormous, launching them is not simple...

Running oncology clinical trials in the US is complex and resource-heavy. Patient recruitment, biomarker testing, data collection, and regulatory reporting all demand specialized expertise. Pharmaceutical companies and biotech sponsors often rely on Contract Research Organizations (CROs) to manage parts or all of the trial process....

Regulation shapes every part of the pharmaceutical industry. Agencies like the WHO, FDA (US), EMA (EU), MHRA (UK), ANVISA (Brazil), NMPA (China), and CDSCO (India) control how drugs are researched, developed, manufactured, and approved.. In 2025, these authorities are updating their frameworks to keep pace with artificial intelligence, digital health, advanced clinical trial models, sustainability rules, and global supply chain standards....

Pharma companies spend billions every year trying to influence doctors, patients, and healthcare systems. Yet clinical data and product claims alone often fail to change outcomes. People rely on habits, emotions, social cues, and mental shortcuts, not just logic. ...

Vaccines are biological products that protect people from infectious diseases by stimulating the body’s immune system. They are one of the most effective tools in public health, reducing illness, saving lives, and lowering healthcare costs.. The demand for vaccines is increasing worldwide due to government immunization programs, new biotechnology platforms like mRNA, and a growing need to prevent both infectious and chronic diseases....

Pharma R&D efficiency is under constant review by executives, investors, and regulators. The cost of bringing a new drug to market has increased, while success rates in clinical trials remain low. At the same time, pressure from pricing reforms, patent expiries, and investor expectations is forcing companies to do more with less....

Cell and gene therapies are changing modern medicine, offering new hope for patients with cancer, genetic disorders, and rare diseases. However, the success of these treatments depends on reliable and scalable manufacturing. Current processes are often complex, slow, and dependent on manual steps that introduce risks....

Daré Bioscience is set to launch DARE to PLAY™ Sildenafil Cream, the first evidence-backed topical treatment for female sexual arousal, in late 2025. Partnering with Rosy Wellness, the company has begun an awareness campaign to reduce stigma and provide women with trusted education and support around sexual health.. A Major Step Forward in Women’s Health...

Cancer drugs remain among the most expensive medicines in healthcare. While innovative treatments bring hope, their high cost often restricts access for patients and strains health budgets. . Generic oncology drugs, both small-molecule generics and biosimilar,s have emerged as the most powerful tool to improve affordability. ...

Zug, Switzerland (June 26, 2025) – Galderma has announced two new Phase II clinical trials to study nemolizumab, a drug designed to block the IL-31 receptor. . These trials will focus on patients with Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO), two conditions with high unmet medical needs and no approved treatments available.. What is Nemolizumab?...

Roche announced significant progress in its Alzheimer’s disease research portfolio during the Alzheimer’s Association International Conference (AAIC) 2025 in Toronto.. The company presented detailed results from its investigational therapy trontinemab and showcased its Elecsys pTau217 blood test, both of which aim to transform the detection and treatment of Alzheimer’s disease.. Advancing trontinemab with Brainshuttle technology...

Cipla Limited has taken significant strides in its respiratory segment with the planned FY26 launch of its generic version of GlaxoSmithKline’s blockbuster asthma and COPD drug, Advair Diskus®, in the United States. . The move follows the successful completion of Phase-3 clinical trials and the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (USFDA).. The Advair Opportunity: A Multi-Billion Dollar Market...

The global vaccine market is changing faster than ever, but many businesses, researchers, and policymakers struggle to keep up with the latest shifts.. Ignoring these changes can mean missed opportunities in investment, technology adoption, and public health preparedness. Falling behind could also leave gaps in vaccine access, innovation, and disease prevention....

Patient segmentation in cardiology helps hospitals and clinics group patients based on health risks, behavior, and outcomes.. This allows care teams to provide better, faster, and more personalized treatment.. With the rise of chronic heart diseases and growing data from EHRs and diagnostic tools, segmentation is now more important than ever....

WAYNE, Pa. (June 2, 2025) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing treatments for immuno-inflammatory diseases, has announced the initiation of a Phase 2 clinical trial of its leading drug candidate, bosakitug (ATI-045)....

Lund, Sweden - April 25, 2025: Camurus has announced a major regulatory milestone as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Oczyesa (CAM2029). This once-monthly treatment is designed for adult patients living with acromegaly, a rare hormonal disorder.. The recommendation is based on strong results from seven clinical trials, including two pivotal Phase 3 studies...

Intuitive’s da Vinci 5 Surgical Robot Approved for Use in Europe. Sunnyvale, California, July 2025 — Intuitive, a global leader in robotic-assisted surgery, has announced that its latest surgical robot, the da Vinci 5 Surgical System, has received CE Mark approval. This approval allows the use of the da Vinci 5 system for both adult and pediatric patients across Europe in a wide range of minimally invasive surgeries, including urologic, gynecologic, and general laparoscopic procedures....

Waltham, Massachusetts, July 28, 2025 — The United States Food and Drug Administration has officially approved Empaveli, also known as pegcetacoplan. This innovative treatment was developed by Apellis Pharmaceuticals. It is now the first approved therapy for two rare and serious kidney diseases...