Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has accepted for Priority Review Regeneron's biologics license application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target action date of August 2026.
Candel Therapeutics announced a $100 million royalty funding agreement with RTW Investments, contingent on FDA approval of aglatimagene besadenovec for intermediate- to high-risk localized prostate cancer, with tiered royalties on U.S. net sales.
NEXT Life Sciences has advanced two male birth control options into Phase II clinical trials: Plan A™, a long-acting reversible system, and NLS-133, a non-hormonal pill designed for on-demand or daily use.
Swiss pharmaceutical major Novartis AG has signed a definitive agreement to sell its entire 70.68% stake in Novartis India to a ChrysCapital-led consortium for Rs 1,446 crore, with a mandatory open offer for an additional 26% from public shareholders.
Scientists in Shanghai have developed DeepRare, an AI system that diagnoses rare diseases with 79% accuracy, outperforming experienced doctors in head-to-head testing. The system is now being used by clinicians at over 600 institutions worldwide.
Novartis AG agreed to sell its entire 70.68% stake in Novartis India to a consortium led by WaveRise Investments, ChrysCapital, and Two Infinity Partners for approximately ₹1,446 crore, triggering a mandatory open offer at ₹860.64 per share.
Swiss drugmaker Novartis will sell its entire 70.68% stake in its listed Indian unit to a private equity consortium for $159 million as part of broader global restructuring. Shares of Novartis India surged nearly 20% following the announcement.
PureTech Health announced that deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for idiopathic pulmonary fibrosis, with a Phase 3 trial planned for the first half of 2026.
A Phase II trial led by WVU Cancer Institute reports the first-ever use of subcutaneous blinatumomab in CD19-positive mixed phenotype acute leukemia, with the first patient achieving complete remission after one cycle.
PureTech Health's deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for treating idiopathic pulmonary fibrosis, a rare and fatal lung disease. Phase 2b trial results showed superior efficacy compared to existing therapies.
AbbVie reported progress on two clinical studies: a Phase 2a trial of ABBV-142 for idiopathic pulmonary fibrosis now recruiting patients, and completion of a JUVÉDERM VOLITE study for facial skin quality improvement.
Eli Lilly's Omvoh demonstrated durable efficacy in Crohn's disease, with over 90% of patients maintaining steroid-free clinical remission through three years of monthly treatment in the Phase III VIVID-2 extension study.
Researchers develop a nanoplatform that co-induces cuproptosis and disulfidptosis to upregulate PD-L1 expression and sensitize tumors to immune checkpoint blockade therapy, addressing resistance in PD-L1-low malignancies.
The FDA will now require a single pivotal clinical trial as the default for novel medicine approvals, replacing its decades-old two-trial standard. The policy aims to reduce development costs and accelerate innovation.
Boehringer Ingelheim India and NIPER Raebareli have signed an MoU to strengthen pharmaceutical education and research collaboration, including access to the company's open science portal and joint initiatives in drug delivery systems.
The U.S. Court of Appeals for the Federal Circuit ruled that Teva Pharmaceuticals did not infringe Corcept Therapeutics' patents for methods of safely co-administering Korlym with CYP3A4 inhibitors, affirming a 2023 district court verdict.
The UK and US announced a pharmaceuticals agreement featuring zero tariffs and a 25% increase in UK spending on innovative medicines. Major pharma M&A deals and regulatory reforms are reshaping the industry in early 2026.
Novartis commits $23 billion to U.S. manufacturing expansion with new facilities in North Carolina, California, and Florida, while advancing its immunoglobulin A nephropathy drug portfolio with positive Phase III results for Vanrafia.
Ten63 Therapeutics announced strategic investment from Chugai Venture Fund and the Gates Foundation, bringing total funding to more than $45 million to advance its BEYOND AI drug discovery platform targeting previously undruggable proteins.
Johnson & Johnson will invest over $1 billion to build a cell therapy manufacturing facility in Montgomery County, Pennsylvania, creating more than 500 jobs over 12 years as part of its $55 billion U.S. expansion plan.
