Policy
Marty Makary's sudden resignation as FDA commissioner leaves the pharmaceutical industry facing regulatory uncertainty at a critical moment for biotech recovery.
Pharmaceuticals
The FDA approves Inqovi in combination with venetoclax as the first all-oral treatment for elderly patients with newly diagnosed AML, eliminating the need for frequent infusion center visits.
Biotechnology
Sarepta's Elevidys gene therapy beats revenue estimates but faces declining sales, revealing the gap between clinical promise and commercial durability in the gene therapy sector.
Biotechnology
argenx's VYVGART receives FDA approval for all generalized myasthenia gravis patients regardless of serotype, including the triple seronegative population previously excluded from treatment options.
Biotechnology
Roche's $1.05 billion acquisition of PathAI signals that AI-powered digital pathology is becoming as strategically important as drug development itself in precision oncology.
Biotechnology
Bayer's $2.45 billion acquisition of Perfuse Therapeutics signals a strategic shift in ophthalmology toward disease-modifying treatments that could reverse vision loss in glaucoma and diabetic retinopathy—conditions affecting over 200 million people worldwide.
Biotechnology
Cytokinetics' ACACIA-HCM Phase 3 trial just delivered the first statistically significant win in non-obstructive HCM. Here is what the data mean, why the disease has been so hard to treat, and what comes next for aficamten and the field.
Biotechnology
In 2021, Pfizer sold a drug candidate for $10 million upfront. This week, that same drug delivered a Phase 3 win that could reshape the treatment of the most common form of breast cancer and generate more than $2 billion in annual sales.
Biotechnology
UCB's $2.2 billion acquisition of Candid Therapeutics signals a fundamental shift in autoimmune treatment strategy. T-cell engagers could reshape immunology the way CAR-T transformed oncology.
Thoughts, stories and ideas.
The FDA has launched proof-of-concept real-time clinical trials with AstraZeneca and Amgen, signaling a fundamental shift in how drug development data is monitored and regulatory decisions are made.
Teva Pharmaceutical Industries' $700 million acquisition of Emalex Biosciences brings ecopipam, a first-in-class D1 receptor antagonist, to pediatric Tourette syndrome treatment—challenging decades of dopamine D2-targeting therapy.
Sun Pharmaceutical's $11.75 billion acquisition of Organon marks a watershed moment in global pharmaceutical consolidation. The deal reveals how Indian drugmakers are evolving from generics suppliers into genuine global players, while exposing the structural pressures reshaping the industry.
Intellia Therapeutics announced positive Phase 3 results from the HAELO trial, marking the first time a Phase 3 clinical trial of an in vivo CRISPR-based gene editing therapy has reported positive outcomes.
On April 23, 2026, the FDA granted accelerated approval to Regeneron's Otarmeni, the first gene therapy ever approved for genetic hearing loss—a breakthrough that represents a categorical shift in what medicine can do.
Kyverna Therapeutics presented groundbreaking KYSA-8 trial data showing that a single CAR-T cell infusion could achieve what years of immunosuppression cannot: a durable immune reset in stiff person syndrome patients, potentially opening an entirely new therapeutic category for autoimmune diseases.
Regeneron's Phase 3 NIMBLE trial data for cemdisiran demonstrates a paradigm shift in myasthenia gravis treatment. A quarterly subcutaneous injection achieves meaningful clinical outcomes with a favorable safety profile, potentially redefining patient care in this chronic neuromuscular disorder.
Trump's executive order fast-tracking FDA review of psychedelic drugs like psilocybin and ibogaine signals a major shift for mental health treatment and the biotech sector.
New pharmacokinetic data shows D-PLEX₁₀₀ delivers 30 days of infection protection using a fraction of the antibiotics used to treat infections today, with minimal to no impact on the rest of the body Think about the last time you were prescribed antibiotics for something routine, like a common bacterial infection.
Kailera Therapeutics' record-breaking $625 million IPO marks a pivotal moment in the obesity drug market, signaling investor confidence in Chinese-origin drug pipelines and validating a new model for biotech fundraising.
A localized radiation platform is showing early clinical promise in pancreatic and other cancers, with a major conference presentation approaching. On April 13, Revolution Medicines (NASDAQ: RVMD) reported that its oral drug daraxonrasib nearly doubled median overall survival in a Phase 3 metastatic pancreatic cancer trial. The stock surged sharply,
Novartis CEO Vas Narasimhan's appointment to Anthropic's board marks a significant shift in pharmaceutical industry governance of AI technology, signaling that pharma is becoming a co-author of AI governance norms.
