Pharmaceuticals
Sentynl Therapeutics receives FDA approval for Zycubo, the first and only treatment for Menkes disease, offering a 10-fold improvement in survival for children with this devastating rare genetic disorder.
Biotechnology
Abbisko Therapeutics' FDA acceptance of pimicotinib NDA marks a significant regulatory milestone in the competitive TGCT market, challenging established players like Deciphera and Daiichi Sankyo.
Why a prevention-first reset could benefit platforms like DarioHealth When Robert F. Kennedy Jr. unveiled a sweeping overhaul of U.S. dietary guidelines in early 2026, the announcement barely mentioned technology companies or digital health platforms. Yet buried inside the policy shift - away from ultra-processed foods and toward whole,
Biotechnology
French biotech 4Moving Biotech achieves FDA IND clearance for 4P004, a first-in-class intra-articular GLP-1 therapy targeting osteoarthritis, potentially becoming the first disease-modifying osteoarthritis drug (DMOAD) to reach patients.
Biotechnology
In a landmark achievement that could transform treatment for one of neuro-ophthalmology's most challenging conditions, Oculis Holding AG announced on January 6, 2026, that the FDA has granted Breakthrough Therapy Designation to Privosegtor for the treatment of optic neuritis. This designation marks the first time any investigational therapy
Biotechnology
Revolution Medicines announces FDA Breakthrough Therapy Designation for zoldonrasib, marking the first investigational drug specifically targeting the KRAS G12D mutation to receive this prestigious regulatory recognition.
Biotechnology
Krystal Biotech announces interim clinical results from its Phase 1 CORAL-1 study of KB407, a potentially mutation-agnostic gene therapy for cystic fibrosis that could transform treatment for all CF patients.
For most investors, “obesity drugs” now means GLP-1s. But not all obesity is lifestyle-driven, and not all patients respond to incretins - hormone-based drugs like GLP-1s that suppress appetite. One of the most severe and underserved forms of obesity - hypothalamic obesity (HO) - sits largely outside the GLP-1 boom.
Biotechnology
Jazz Pharmaceuticals announces unprecedented survival outcomes for Ziihera in HER2-positive gastroesophageal adenocarcinoma, achieving over two years median overall survival—the longest ever reported in a Phase 3 trial for this disease.
Thoughts, stories and ideas.
In modern oncology, progress is often defined less by discovering new drugs than by understanding why good drugs stop working. Few therapies illustrate that challenge more clearly than AstraZeneca’s Tagrisso (osimertinib), the backbone treatment for patients with EGFR-mutated non-small cell lung cancer (NSCLC). Tagrisso generates more than $6 billion
GSK and Ionis announce historic functional cure rates for chronic hepatitis B in Phase III trials with bepirovirsen, potentially transforming treatment for 250 million patients worldwide.
New ASCO data from Alpha Tau Medical (NASDAQ: DRTS) shows immune markers remain stable after treatment, a finding that could open the door to combination therapies in one of oncology's deadliest cancers. Pancreatic cancer is the third leading cause of cancer death in the United States. It kills
In May 2024, AstraZeneca completed a $1.05 billion acquisition of Amolyt Pharma, securing eneboparatide – a daily injectable therapy for hypoparathyroidism that had demonstrated promising Phase 2 data but had not yet completed Phase 3. The deal reflected big pharma's conviction that hormone replacement for hypoparathyroidism represents a
MediWound has a product already on the market, no long-term debt, substantial non-dilutive government funding, and a Phase III asset going after a market dominated by a single 60-year-old drug Chronic wounds are not something most investors think about. But they should. More than 10 million Medicare beneficiaries in the
Fractyl Health outlines ambitious 2026 roadmap positioning its Revita system as the first FDA-approved solution for maintaining weight loss after GLP-1 discontinuation, with pivotal clinical data expected this month.
GLP-1 drugs have reshaped the treatment of obesity and diabetes, and innovation in the category is accelerating. The FDA approval of an oral version of Wegovy for chronic weight management marked a major milestone, expanding access to GLP-1 therapy and offering a new option for patients reluctant to use injections.
Ascletis Pharma announced FDA IND clearance for ASC30, an oral small molecule GLP-1 receptor agonist for diabetes treatment, marking a significant milestone in the competitive GLP-1 market with a differentiated approach to injectable peptide therapies.
January 4, 2026, marks a watershed moment in the global GLP-1 market as Canada becomes the first country where Novo Nordisk's blockbuster diabetes and weight-loss drug Ozempic loses patent protection. Leading the charge into this newly opened market is Toronto-based Vimy Pharma, a startup founded by former Novo
Insilico Medicine announces an $888 million multi-year collaboration with Servier, representing one of the largest AI-driven drug discovery deals to date and validating the commercial viability of AI in pharmaceutical research.
Axsome Therapeutics announces FDA Priority Review for AXS-05 in treating Alzheimer's disease agitation, with a PDUFA target action date of April 30, 2026, offering hope for millions affected by this challenging behavioral symptom.
Johnson & Johnson's termination of its Phase 2b study for JNJ-95475939 serves as a stark reminder that even the world's largest healthcare companies face brutal realities in drug development, despite investing $1.25 billion in the acquisition just 18 months earlier.
