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U.S. Food and Drug Administration Approves Opdivo® (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma
3/7/2024
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.
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Columvi (glofitamab for injection) receives positive CADTH and INESSS recommendations for adult patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL)
3/7/2024
Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on March 5, 2024, the Institut National d'Excellence en Santé et en Services Sociaux (INESSS) recommended Columvi® (glofitamab for injection) for public reimbursement.
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Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene.
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RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
3/1/2024
Johnson & Johnson (NYSE: JNJ) announced today that following a priority review, the U.S. Food and Drug Administration (FDA) has approved RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test.
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Johnson & Johnson and Legend Biotech got a positive opinion from a European Medicines Agency panel for earlier lines of treatment, as they ready for a March FDA advisory committee meeting.
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Legend Biotech Announces Positive CHMP Opinion for CARVYKTI® (ciltacabtagene autoleucel) for the Treatment of Patients with Relapsed and Lenalidomide Refractory Multiple Myeloma in Earlier Lines of Therapy
2/23/2024
Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech) announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expansion of the CARVYKTI® label to include adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.
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Johnson & Johnson’s anti-BCMA antibody can now be dosed once every two weeks in relapsed or refractory multiple myeloma patients who have achieved and maintained complete response for at least six months.
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New England Journal of Medicine Publishes Results of Positive Randomized Phase 2 REVIVE Trial of Rusfertide in Treatment of Polycythemia Vera
2/21/2024
Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or the "Company") today announced publication in the New England Journal of Medicine (NEJM) of the REVIVE Phase 2 study (NCT04057040) results evaluating the efficacy and safety of rusfertide in polycythemia vera (PV), a myeloproliferative neoplasm affecting approximately 160,000 patients in the United States (US).
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Immix Biopharma 12 Month Review Progress Update
2/21/2024
Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced its 12-month progress update including shareholder letter.
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FDA Grants Priority Review to Merck's Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma
2/20/2024
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA.
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TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma
2/20/2024
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months.
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PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) Granted Priority Review by Japan's Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer
2/15/2024
Astellas Pharma Inc. announced that Japan's Ministry of Health, Labour and Welfare has granted priority review for the company's Supplemental New Drug Application for PADCEV™ with KEYTRUDA® as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer.
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Baxter Reports Fourth-Quarter and Full-Year 2023 Results
2/8/2024
Baxter International Inc. (NYSE:BAX), a global medtech leader, today reported results for the fourth quarter and full year ended Dec. 31, 2023, and provided its financial guidance for full-year and first-quarter 2024.
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Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable Non-Small Cell Lung Cancer
2/7/2024
Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable Non-Small Cell Lung Cancer.
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The monoclonal antibody Nipocalimab, which J&J acquired from Momenta Therapeutics, met its primary endpoints in mid-stage and late-stage trials in myasthenia gravis and Sjögren’s disease.
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Johnson & Johnson reports positive topline results for nipocalimab from a Phase 3 pivotal study in generalized myasthenia gravis (gMG) and a Phase 2 study in Sjögren's Disease (SjD)
2/5/2024
Johnson & Johnson today announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG) as well as the Phase 2 DAHLIAS study of nipocalimab in adults with Sjögren's disease (SjD).
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The U.S. Department of Health and Human Services on Thursday released new data showing that Americans pay three times more for prescription drugs than other developed countries and nearly 10 times more for insulin.
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Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2023
2/2/2024
Bristol Myers Squibb (NYSE: BMY) today reports results for the fourth quarter and full year of 2023, which reflect strong pipeline acceleration, continued portfolio diversification, and momentum in our business.
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Tisotumab Vedotin Marketing Authorization Application Validated by European Medicines Agency for Treatment of Recurrent or Metastatic Cervical Cancer
2/2/2024
Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE PFE) today announced that the European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug conjugate (ADC), developed for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
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Align Technology Announces Fourth Quarter and Fiscal 2023 Financial Results
1/31/2024
Align Technology, Inc., a leading global medical device company that designs, manufactures, and sells the Invisalign® system of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, reported financial results for the fourth quarter and year ended December 31, 2023.