FDA
The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agency’s 79 total approvals, including supplemental nods.
FEATURED STORIES
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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The U.S. Food and Drug Administration (FDA) gave the thumbs-up to Boehringer Ingelheim’s Ofev (nintedanib) for systemic sclerosis-associated interstitial lung disease (SSc-ILD).
The U.S. Food and Drug Administration (FDA) gave tentative approval to Mylan’s pemetrexed, a generic version of Eli Lilly’s $2 billion lung cancer drug, Alimta.
CrystalGenomics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CG-745, a clinical stage histone deacetylase (HDAC) inhibitor being developed for several hematologic malignancies and solid tumors, for the treatment of patients with pancreatic cancer.
Oncoceutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for ONC206, allowing the first-in-human trial of the compound. ONC206 is the first of the family of drug candidates, which we call “imipridones”, that possess the same core chemical structure as ONC201.
It takes on average five years before the confirmatory trial is even started.
Nourianz (istradefylline) was given the thumbs-up as an add-on treatment to levodopa/carbidopa in adults with Parkinson’s disease who experience “OFF” episodes.
The U.S. FDA gave Nabriva Therapeutics a thumbs-up for both its oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.
AbbVie’s JAK inhibitor Rinvoq was approved by the U.S. Food and Drug Administration for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
The U.S. Food and Drug Administration approved Impact’s Inrebic for the treatment for adult patients with certain types of myelofibrosis, cancers of the bone marrow.
The FDA approved Rozlytrek for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. Also, Rozlytrek secured accelerated approval for the treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.