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Apr 17, 2026
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.
Apr 18, 2026
The FDA approved acalabrutinib plus venetoclax for previously untreated CLL/SLL based on phase 3 AMPLIFY data. The fixed 14-month regimen improved progression-free survival versus chemotherapy.
Apr 18, 2026
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.
Apr 18, 2026
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.
Apr 18, 2026
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.
Apr 17, 2026
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.
Apr 18, 2026
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.
Apr 17, 2026
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.
Apr 17, 2026
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.
Apr 17, 2026
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.
Apr 16, 2026
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.
Apr 16, 2026
The FDA approved once-monthly subcutaneous amivantamab with lazertinib for first-line EGFR-mutated advanced NSCLC. PALOMA-2 showed high response rates and no new safety signals.
Apr 16, 2026
A new Cochrane review said anti-amyloid Alzheimer’s drugs show no clinically meaningful benefit, but many researchers said the analysis has major limitations. Newer evidence on lecanemab and donanemab and broader drug development efforts continue to shape the field.
Apr 15, 2026
The FDA has expanded animal drug options for New World screwworm through conditional approvals and emergency use authorizations. The agency lists products for cattle, dogs and cats and says its guidance page will be updated as more drugs move through the system.
Apr 15, 2026
Heather Quintana Suchan said early biomarker testing and genomic profiling identified an exon 20 mutation and helped match her to Rybrevant for stage 4 lung cancer. She said the treatment is working well with minimal side effects and is urging patients to seek personalized testing early.
Apr 15, 2026
The global healthcare contract research organization market is estimated at USD 60.66 billion in 2025 and is expected to reach USD 124.56 billion by 2035. North America led in 2025, while Asia Pacific is projected to post the fastest growth.
Apr 15, 2026
Lenacapavir was launched in Zimbabwe in February 2026 as Kenya became the fourth African country to start administering the twice-yearly HIV prevention injection. The rollout follows launches in Eswatini and Zambia in December 2025, five months after US FDA approval.
Apr 14, 2026
The US Food and Drug Administration sent messages on 30 March to more than 2,200 companies and researchers tied to over 3,000 clinical trials over missing ClinicalTrials.gov results. The agency said 29.6% of studies highly likely to be subject to mandatory reporting had no results information submitted.
Apr 14, 2026
Breath Diagnostics said the FDA granted Breakthrough Device Designation to its OneBreath platform for pre-operative assessment of postoperative pneumonia risk in adults undergoing elective cardiac surgery. The single-breath test analyzes exhaled volatile organic compounds using LC-MS and is intended for use with clinical evaluation and standard risk assessment tools.
Apr 14, 2026
The FDA accepted Praxis Precision Medicines' NDA for ulixacaltamide in essential tremor and set a Jan. 29, 2027 PDUFA date. The filing is backed by positive Phase 3 Essential3 data.
