Clinical trials on Bench to Bed: Phase 1, 2, 3 and 4 explained, randomisation, blinding, control arms, primary and secondary.
The FDA announced the Rare Disease Framework Initiative on October 14, 2026, to create a tailored regulatory pathway for rare disease treatments, addressing the unmet need for the 30 million Americans affected.
Bristol Myers Squibb's Phase 3 trial of admilparant for idiopathic pulmonary fibrosis met its primary endpoint only at the lower 60 mg dose, raising questions about dose response despite a positive safety profile.
BioNTech's mRNA cancer therapy BNT113 combined with Keytruda did not improve progression-free survival in a Phase 3 trial for HPV-driven head and neck cancer. The trial will continue to assess overall survival.
Viatris is buying Pacira BioSciences for $1.65 billion in cash to acquire its two major non-opioid pain drugs, Exparel and Zilretta, expanding its portfolio amid looming generic competition.
ArriVent BioPharma's oral lung cancer drug furmonertinib failed to significantly delay tumor progression versus chemotherapy in a late-stage study, missing its primary endpoint despite a modest numerical benefit and triggering a sharp drop in the company's share price.
Amgen's experimental drug dazodalibep met its primary goal in a Phase 3 study for Sjögren's syndrome, showing early and sustained symptom improvement.
Novartis has licensed a preclinical radioligand therapy from China's BoomRay Therapeutics in a deal worth up to $900 million.
The FDA has opened a pilot program pairing drug sponsors with qualified research institutions to expedite IND reviews.
The phase III EVOKE-03 trial found adding sacituzumab govitecan to pembrolizumab did not significantly improve survival in untreated metastatic non-small cell lung cancer.
In a phase 3 trial, adding zipalertinib to chemotherapy improved median progression-free survival to 14.5 months, a six-month gain over chemo alone.
GSK and Hansoh Pharma's antibody-drug conjugate risvutatug rezetecan achieved a median overall survival of 18.5 months in a phase 3 trial for relapsed small cell lung cancer.
Roivant's mosliciguat reduced a key lung pressure measure by 56% in a Phase 2 trial for PH-ILD, with analysts citing multi-billion dollar potential.
ADARx Pharmaceuticals has filed for an initial public offering to raise funds for advancing its pipeline of siRNA therapies.
Novo Nordisk has discontinued two late-stage heart failure trials for its drug ziltivekimab after a data review.
Akeso and Summit Therapeutics report their bispecific antibody ivonescimab helped lung cancer patients live longer than those on Merck's Keytruda.
Novartis and Ionis Pharmaceuticals' experimental drug pelacarsen failed to reduce heart attacks, strokes or death in a Phase 3 study of over 8,000 people.
AbbVie reported that its bispecific antibody etentamig met the primary endpoint in a Phase 3 trial for multiple myeloma.
Novartis and Bristol Myers Squibb have paused multiple trials of their CAR-T therapies for autoimmune diseases following serious safety incidents.
Major U.S. medical societies have released independent guidelines for flu, Covid-19, and RSV vaccinations this winter.
Novartis and Bristol Myers Squibb have paused clinical trials of their CAR T-cell therapies for autoimmune diseases following severe adverse events.
Natera has partnered with Angiex to evaluate its Signatera blood test in a phase 1 trial of the cancer drug AGX101.
Novartis paused CD19 CAR-T trials after three patient deaths, and Bristol Myers Squibb halted enrollment in a similar program due to inflammatory events.
A pooled analysis of 38,753 patients from nine trials provides individualized estimates for how combinations of modern heart failure drugs affect blood pressure, kidney function, and potassium levels.
A personalized mRNA vaccine for melanoma from Moderna and Merck has shown clinical success.
Syneos Health advises biotechs to integrate China into global clinical development from the outset.
AstraZeneca and Amgen's Tezspire succeeded in a Phase 3 trial for eosinophilic esophagitis, potentially expanding the label for the immunology drug.
AusperBio Therapeutics raised $120 million in a series C round led by RA Capital to advance its hepatitis B drug candidate AHB-137 into phase 3 trials.
The FDA has approved Rasonque, a new pancreatic cancer drug by Revolution Medicines, marking the first treatment to target a genetic cause of the disease. The approval follows a clinical trial showing improved survival in second-line patients.
Akeso’s CEO highlights a phase-3 success in biliary tract cancer while defending the drug’s data amid NSCLC concerns.
The TALENTOP study, a multicentre, open-label, randomised phase 3 trial, compares liver resection after atezolizumab and bevacizumab with maintenance therapy in patients with locally advanced hepatocellular carcinoma. The study is discussed in a comment by Fornera et al. In The Lancet, highlighting the evolving role of immunotherapy and conversion surgery in advanced HCC.
Moderna and Merck's individualized cancer vaccine shows promise in Phase 3 trial for melanoma.
Researchers and regulators are working to integrate traditional medicines into modern clinical care.
The FDA's recent decision on Capricor’s deramiocel for Duchenne muscular dystrophy underscores the complexities of rare disease clinical trials, where small design choices can have significant impacts on outcomes and regulatory approval.
Researchers at Harvard have successfully kept brain organoids alive for over five years, observing a maturation process similar to that of human brains.
The White House is expected to nominate Heidi Overton as the next commissioner of the U.S. Food and Drug Administration. Meanwhile, a late-stage clinical trial has shown promising results for a personalized mRNA cancer vaccine.