FDA plans to make one study the default for some new drug approvals
The FDA plans to make one study the default for some new drug approvals instead of two robust clinical trials. The shift could have its biggest effect on drugs for common ailments.
News & Analysis
Curated news and analysis on clinical trials, drug approvals, and medical research.
Bruker, Jackson Laboratory, Ribbon Bio, and Human Longevity Announce Leadership Moves
Bruker, The Jackson Laboratory, Ribbon Bio, and Human Longevity announced leadership and advisory changes. The updates include Falko Busse's transition at Bruker and new appointments at the other companies.
CAMP4 Therapeutics Announces Nasdaq Inducement Grants to Newly Hired Employees
CAMP4 Therapeutics announced Nasdaq inducement stock option grants for newly hired employees in February and April 2026. The awards covered 51,000 shares in total and vest over four years.
Revolution Medicines says daraxonrasib extended survival in phase 3 pancreatic cancer study
Revolution Medicines said daraxonrasib extended median survival to 13.2 months versus 6.7 months for chemotherapy in a phase 3 pancreatic cancer study. The company plans to seek FDA approval for the KRAS-targeting pill.
Quantum chemistry studies report advances in molecular simulations for drug-like molecules
Two quantum chemistry studies reported advances in molecular simulation. One used a 24-qubit superconducting processor to simulate water and Amantadine, while another used machine learning to deliver stable orbital-free calculations for larger drug-like molecules.
FDA updates Vabysmo label to allow extended RVO macular edema treatment
The FDA approved updated labeling for Vabysmo to allow extended treatment of macular edema following retinal vein occlusion beyond six months. The label update removes the prior 6-month restriction and retains monthly 6 mg intravitreal dosing.
FDA crackdown puts focus on risks of compounded GLP-1 weight-loss drugs
The FDA has announced plans to crack down on active pharmaceutical ingredients used in compounded GLP-1 drugs and warned about the risks of these products. The agency has cited counterfeit products, non-FDA-approved ingredients and more than 1,000 adverse event reports tied to compounded semaglutide and tirzepatide.
AbbVie reports record 2025 results as Merit Financial Group raises stake
AbbVie reported full-year adjusted EPS of $10 and total net revenue of $61.2 billion for 2025. Merit Financial Group raised its fourth-quarter stake in the company to 93,295 shares worth $21.317 million.
European Commission approves Enflonsia for infants’ first RSV season as Merck reports new SMART data
The European Commission approved Enflonsia for prevention of RSV lower respiratory tract disease in infants during their first RSV season. Merck also reported new Phase 3 SMART data showing generally consistent second-season safety in high-risk children under 2 years old.
FDA grants breakthrough designation to two rapid tests for drug-resistant pathogens
The FDA granted Breakthrough Device Designations to NG-TEST® Candida auris and NG-TEST® Acineto-5®, two rapid assays targeting critical drug-resistant pathogens. Both tests deliver results within 15 minutes and are currently available for Research Use Only while FDA review continues.
Digital tools and predictive models gain ground in drug discovery
Digital drug design tools and AI are gaining ground as drug development timelines run 10 to 14 years and approval rates remain low. Recent work describes broader AI adoption and an information-theoretic predictive model for drug design.
Middle East and Africa biosimilars market seen reaching $5.73 billion by 2035
The Middle East and Africa biosimilars market is estimated to grow from USD 1.15 billion to USD 5.73 billion by 2035 at a 19% CAGR. Monoclonal antibodies hold almost 55% of market share, while oncological disorders dominate demand.
FDA extends review of Savara's MOLBREEVI application in autoimmune PAP
The FDA extended by three months the review period for Savara's MOLBREEVI biologics license application in autoimmune pulmonary alveolar proteinosis, moving the PDUFA date to Nov. 22, 2026. Savara had previously said the FDA filed the application after a resubmission tied to manufacturing data and a transfer to Fujifilm.
Spyre Therapeutics details ECCO presentations and SPY003 Phase 1 follow-up
Spyre Therapeutics announced ECCO 2026 presentations featuring 20-week follow-up from the Phase 1 SPY003 study and details of the SKYLINE-UC platform study. The company is also seeking to raise $403 million in a follow-on stock offering.
Europe Infusion Pump Market Projected to Reach USD 7.09 Billion by 2031
Europe's infusion pump market is projected to reach USD 7.09 billion by 2031 at a 6.8% CAGR. Growth is driven by connected systems, tighter safety standards, homecare use, and diabetes demand.
Gotistobart shows early survival advantage over docetaxel in pretreated squamous NSCLC
Early results from stage I of the phase 3 PRESERVE-003 trial showed gotistobart improved overall survival versus docetaxel in previously treated metastatic squamous NSCLC. Objective response rate and duration of response also favored gotistobart, while progression-free survival did not differ significantly.
DOE streamlines reactor authorization process for advanced reactor testing
The U.S. Department of Energy revised its reactor authorization process to speed advanced reactor review and construction. The pathway cuts 17 steps to 11 and removes more than 900 pages from prior guidance.
Needle-Free Allergy Therapy and House Dust Mite Treatment Markets Forecast Strong Growth
Needle-free allergy therapy is forecast to expand through 2035 as self-administered options gain share. House dust mite allergy treatment is projected to grow from $3.18 billion in 2025 to $8.75 billion by 2033.
Algorithmiq, Cleveland Clinic and IBM win $2 million Q4Bio prize
Algorithmiq, Cleveland Clinic and IBM earned the $2 million Q4Bio prize after using quantum computing to simulate key processes in photodynamic therapy. The Wellcome Leap program launched with $40 million in funding, and five of six Phase III finalists used IBM quantum hardware.
Mesoblast and Satellos advance Duchenne muscular dystrophy treatment trials
Mesoblast received FDA clearance for a registrational DMD trial of remestemcel-L-rknd, while Satellos began dosing boys in the Phase 2 BASECAMP study of SAT-3247. The studies are enrolling children ages 5-9 and 7-9, respectively.
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