The FDA's finalized guidance on psychedelic drug development provides the clearest regulatory roadmap yet for companies developing psilocybin, MDMA, and related compounds as treatments for psychiatric disorders.
Samsung Biologics' $1.81 billion bid for Swiss peptide manufacturer PolyPeptide Group is not just an M&A story. It is a strategic play for control of the GLP-1 drug supply chain, and a signal of where the CDMO industry is heading.
Merck's $31.7 billion oncology drug has transformed oncology, but combining immunotherapy with radiation remains a major challenge. Tomorrow, Alpha Tau will present the first prospective data testing whether its targeted alpha radiation can change that equation.
Merck's enlicitide becomes the first oral PCSK9 inhibitor approved by the FDA, potentially transforming cholesterol treatment by eliminating the need for injections.
How a drug rescued from Pfizer's shelf became Revtorpyk, the first medicine to simultaneously block all major components of the PI3K/AKT/mTOR pathway in breast cancer—and what it means for oncology's future.
Biogen's tau-targeting drug BIIB080 demonstrates a 26% slowing of cognitive decline, matching approved Alzheimer's therapies and potentially validating an entirely new treatment category for the disease.
A first-in-human study from Northwell Health's Feinstein Institutes shows that a wearable ear device can activate the vagus nerve to accelerate blood clotting, opening a new frontier in bioelectronic medicine for hemorrhage control.
GSK and Hansoh's ris-rez became the first B7-H3-targeted ADC to demonstrate an overall survival benefit in a Phase 3 trial. Here is what the ARTEMIS-008 result means for small-cell lung cancer patients, the ADC field, and GSK's oncology ambitions.
AstraZeneca and Ionis's eplontersen failed the CARDIO-TTRansform Phase 3 trial in ATTR-CM. The result reveals a deeper challenge: what happens when the standard of care evolves faster than the trial designed to test against it.
The FDA approved Trutakna (atacicept) for IgA nephropathy on July 7, 2026, making it the first BAFF/APRIL dual inhibitor cleared for the disease. Here is what the approval means for patients, the competitive landscape, and the science of kidney disease.
The FDA's expansion of Casgevy to children as young as 2 years old marks a milestone for CRISPR gene therapy, but significant access barriers remain a critical challenge for families.
For five years, the KRAS G12C inhibitor market in lung cancer has been a story of scientific triumph and commercial disappointment. Amgen's Lumakras and Bristol Myers Squibb's Krazati were genuine breakthroughs when they launched in 2021 and 2022, respectively. They proved that KRAS, long considered undruggable,
Biotechnology
On July 29, an FDA advisory committee will evaluate deramiocel, Capricor's allogeneic cell therapy for Duchenne muscular dystrophy cardiomyopathy. If approved, it would be the first cell-based therapy targeting DMD cardiac dysfunction.
Biotechnology
Anthropic's announcement of Claude Science and its internal drug discovery program signals a major shift in how AI companies are approaching the life sciences—and what it means for pharmaceutical companies.
Biotechnology
Abivax's obefazimod showed impressive efficacy for ulcerative colitis but triggered investor panic over cancer signals. The June 29 data clarified the picture, revealing cancer rates consistent with disease background. Here's what the science actually shows.
Biotechnology
Ipsen's $1.75 billion acquisition of Kartos Therapeutics brings navtemadlin, a novel MDM2 inhibitor, to myelofibrosis patients who have failed ruxolitinib. The drug targets a complementary pathway with promising Phase 1b/2 data showing disease modification signals.
Biotechnology
Viridian Therapeutics' Lumvoa becomes the second FDA-approved treatment for thyroid eye disease, offering new hope for patients with both active and chronic TED.
Pharmaceuticals
The FDA's approval of Ionis's Tryngolza for severe hypertriglyceridemia marks a pivotal moment for RNA medicine, expanding the drug's reach to three million Americans and signaling that RNA-targeting therapies can compete in large, prevalent disease populations.
Biotechnology
A clinical trial about to begin in the DRC will test the first antivirals against Bundibugyo ebolavirus in a randomized controlled trial. What happens over the coming weeks will matter far beyond the outbreak itself.
Biotechnology
China's approval of CARsgen's satri-cel marks the world's first CAR-T therapy for solid tumors. Here's what it means for the future of cellular immunotherapy and the long-standing barrier between engineered T cells and solid tumor oncology.
Biotechnology
Definium's Phase 3 trial shows DT120, an LSD-based treatment, produced an 8.1-point placebo-adjusted improvement in depression symptoms at six weeks with effects visible within the first week.
Biotechnology
Nuvectis Pharma (NASDAQ: NVCT) just joined Lilly, AbbVie, and Merck as a Haisco in-licensor, acquiring ex-China rights to two late-stage assets for $40M upfront and up to $1.42B in milestones - a PNH drug with 7x superiority over Soliris in Phase 3, and a next-gen BRAF inhibitor for $20B+ markets.
Pharmaceuticals
AbbVie's $10.9 billion acquisition of Apogee Therapeutics signals a strategic shift in immunology drug development. The deal centers on zumilokibart, a long-acting IL-13 inhibitor designed to compete with Dupixent through superior dosing convenience.
Pharmaceuticals
On June 18, 2026, an FDA panel voted unanimously to advance Moderna's mRNA flu vaccine, mFlusiva. But the real story isn't the vote—it's the extraordinary regulatory turmoil that preceded it, and what it reveals about vaccine policy in America.