
Today on Drug Discovery & Development
FDA issues final PDUFA meeting guidance, expands use of written responses
The FDA has finalized new guidelines for meetings between the FDA and sponsors or applicants relating to the development and review of drugs or biological products under the Prescription Drug User Fee Act (PDUFA). The FDA first published the draft guidance on Sept. 22, 2023, when it collected public comment on the guidelines. The final guidelines contain several changes from the draft, including modifying when INTERACT…Gilead and Nucleai probe why target-positive tumors can still resist ADCs
Antibody-drug conjugates (ADCs) have emerged as one of the busiest and most crowded niches within oncology, given their potential to use an antibody to ferry a potent cytotoxic payload toward tumor cells. The class now spans about 15 FDA-approved products, and the segment is growing steadily. Evaluate Pharma projects the ADC category will reach $57…Drug Discovery and Development See More >

Sai Life Sciences’ bet on information-dense scale-up and how it is responding to pharma clients who want acceleration
Why has it taken so long, historically, to bring a new drug to market? In a word: complexity. At one end of the spectrum, there is the complexity of disease, genetic variability, the presence of environmental variables that cause patients to respond differently to the same treatment. The thread extends into clinical development, where the…

Ahead of PharmSci 360, DigiM CEO on turning hidden microstructures into drug-release predictions

CEO of CDMO AustinPx on its exclusive agreement with Thermo Fisher’s Patheon division

Top pharma companies set sustainability goals, but emissions are still increasing

SLAS 2026: Orchestration patforms, API-first instruments and the rise of semiautonomous labs
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Genomics/Proteomics See More >

New cell imaging method reveals hidden enzyme activity
Negative biosensors have often been unusable because, as the sensors lose signal when activity is detected, regions of high enzyme activity can look identical to regions with no activity. Researchers at the University of Illinois Chicago have solved this problem with a new cell imaging method that allows scientists to see previously hidden enzyme activities by flipping the optical readout of…

Beyond the silver bullet: Why precision medicine is the next frontier for the $1 trillion obesity market

Columbia-CZ team develops 10.3M parameter model that outperforms 100M parameter rivals on cell type classification

Spatial biology: Transforming our understanding of cellular environments

Biotech in 2025: Precision medicine, smarter investments, and more emphasis on RWD in clinical trials
Infectious Disease See More >

As measles cases hit a 35-year high, Trump executive order backs a narrower childhood vaccine list
The U.S. entered August with more measles cases so far this year than it recorded during all of 2025. With kindergarten MMR coverage down to 92.5% from 95.2% before the pandemic, and Stanford modeling published in JAMA projecting measles could become endemic again within roughly two decades at current rates, President Donald Trump issued a…
Oncology See More >

As chemo overtreatment comes into focus, Atossa bets on tamoxifen’s active form
As evidence mounts that some hormone receptor-positive, HER2-negative breast cancer patients are being overtreated with chemotherapy, researchers are working to identify which patients can safely avoid it, and to expand the treatment options available to those who can. Atossa Therapeutics thinks endoxifen, the active metabolite behind tamoxifen, could be an important addition to that toolkit. …

How ConcertAI turned CancerLinQ into a point-of-care oncology intelligence platform

Moderna bets on mRNA’s second act with cancer, autoimmune programs and AI research platform

Calderasib’s real innovation: designed for combinability and potency




























