Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has approved a supplemental new drug application for the combination regimen of Venclexta (venetoclax) and acalabrutinib for previously untreated adult patients with chronic lymphocytic leukemia, supported by Phase 3 AMPLIFY trial data.
The FDA approved AbbVie's combination of Venclexta and acalabrutinib as the first all-oral, fixed-duration treatment for previously untreated chronic lymphocytic leukemia patients, based on Phase 3 trial data showing 35% reduction in disease progression risk.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration regimen for previously untreated chronic lymphocytic leukemia, based on phase III AMPLIFY trial results showing 35% reduction in disease progression or death risk versus chemoimmunotherapy.
The FDA has approved the combination of Venclexta (venetoclax) plus acalabrutinib as the first all-oral, fixed-duration regimen for previously untreated adults with chronic lymphocytic leukemia, based on Phase III AMPLIFY study results.
The FDA has accepted Roche's new drug application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated breast cancer, with a decision expected by December 18, 2026.
The FDA has accepted a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.
Private prescriptions for GLP-1 weight-loss drugs in England are concentrated in affluent areas despite higher obesity rates in deprived regions. Online pharmacies face scrutiny for inadequate verification checks when dispensing these medications.
The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.
The FDA has accepted Roche's New Drug Application for giredestrant plus everolimus to treat ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is based on phase III data showing significant reductions in disease progression risk.
Novartis AG sells 70.7% stake in its Indian unit to a private equity consortium led by WaveRise Investments for $159 million, marking a complete exit from the listed subsidiary while retaining its commercial operations.
Novartis AG sells its entire 70.68% stake in Novartis India Ltd. for $159 million to a consortium of investors, concluding a two-year strategic review while maintaining operations through its wholly-owned Indian subsidiary.
Grail's multi-cancer blood test failed to significantly boost early detection or reduce late-stage diagnoses in a 142,000-person UK trial, raising doubts about regulatory approval and commercial prospects.
A study published in Science sequenced cancer-related genes in 493 cat tumor samples across 13 cancer types, revealing striking genetic similarities with human cancers and opening possibilities for shared treatments.
The FDA has accepted Teva Pharmaceutical's New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine extended-release injectable suspension for treating schizophrenia in adults, supported by Phase 3 SOLARIS trial data.
BioNTech filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging that Moderna's next-generation COVID-19 vaccine mNEXSPIKE violates its mRNA vaccine design patent.
President Trump announced that Novartis CEO met with him at the White House and said the Swiss drugmaker is building 11 U.S. plants following tariff policies. Novartis previously committed $23 billion to expand U.S. facilities.
Novartis India shares hit upper circuit after Swiss parent agreed to sell 70.68% stake to ChrysCapital-led consortium for Rs 1,445.89 crore. Meanwhile, Novartis AG shares have returned 35.5% over one year, trading at CHF126.46.
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.
