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LYT-200 is a monoclonal antibody designed to block a foundational immunosuppressive protein, galectin-9, which is associated with poor survival rates for a number of cancers Trial will assess safety and [...]

SOUTH SAN FRANCISCO, Calif. -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto[TM] [...]

- Disease stabilized in 10 of 17 patients with relapsed or refractory metastatic solid tumors - First-in-human study showed persistence of T cells in blood and increases in T cell [...]

- Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers - - Genentech and Blueprint Medicines will co-commercialize Gavreto in the United States - - FDA also [...]

FDA-approved plasma-based companion diagnostic provides advantages for patients and practices BOULDER, Colo. -- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) approved the [...]

CAMBRIDGE, Mass. -- Checkmate Pharmaceuticals, Inc. (Checkmate), a clinical-stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, today announced that [...]

KEYTRUDA Is the First Single-Agent, Anti-PD-1 Therapy Approved for the First-Line Treatment of These Patients Approval Received Less Than One Month Following Submission of sBLA Application Based on Results of [...]

Approval Marks First Indication for KEYTRUDA in cSCC KENILWORTH, N.J. -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and [...]

KEYTRUDA Is Now Approved for Adult and Pediatric Patients with Unresectable or Metastatic Tumor Mutational Burden-High (TMB-H) [10 Mutations/Megabase] Solid Tumors, as Determined by an FDA-Approved Test, That Have Progressed [...]

- Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma - - Tecentriq combination improved overall [...]

In CheckMate -9LA, Opdivo + Yervoy combined with two cycles of chemotherapy demonstrated superior overall survival versus chemotherapy, regardless of PD-L1 expression or tumor histology1 Approval marks sixth indication for [...]

In CheckMate -227 Part 1a, Opdivo + Yervoy showed superior and durable long-term overall survival versus chemotherapy1,2,3 Fifth indication for Opdivo + Yervoy, the first and only FDA-approved dual immunotherapy [...]

* Open-label, randomized Phase 2 study will evaluate combination immunotherapy, including NantKwest's PD-L1 tumor-targeted natural killer cells and ImmunityBio's IL-15 superagonist N-803 with standard of care versus standard of care [...]

* Submission based on pivotal phase 2 DESTINY-Gastric01 and phase 1 trial data * Trastuzumab deruxtecan to receive expedited review by Japan MHLW based on SAKIGAKE designation for second potential [...]

CAMBRIDGE, Mass. -- Foundation Medicine, Inc. today announced that FoundationOne[R]CDx has been approved by the U.S. Food and Drug Administration (FDA) for use as the companion diagnostic (CDx) to aid [...]

- Tabrecta is the first and only U.S. Food and Drug Administration (FDA)-approved treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) with a mutation that leads to [...]

REHOVOT, Israel & WILMINGTON, Del. -- Ayala Pharmaceuticals, Inc., a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today [...]

LOS ANGELES -- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for neratinib in [...]

Application based on results from Part 1 of Phase 3 CheckMate -227 study PRINCETON, N.J. -- Bristol-Myers Squibb Company (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) [...]

- Approval based on the Phase III IMpower130 study showing the Tecentriq plus chemotherapy combination demonstrated a significant overall survival and progression-free survival benefit - SOUTH SAN FRANCISCO, Calif. -- [...]

Propanc Developing Backup Synthetic Compound to Lead Product Candidate, PRP MELBOURNE, Australia -- Propanc Biopharma, Inc. (OTC: PPCB) ('Propanc' or the 'Company'), a biopharmaceutical company developing new cancer treatments for [...]

Opinion Supports Use of KEYTRUDA, as Monotherapy or in Combination with Platinum and 5-Fluorouracil Chemotherapy, in Patients Whose Tumors Express PD-L (CPS 1) KENILWORTH, N.J. -- Merck (NYSE: MRK), known [...]

DALLAS -- Susan G. Komen[R], the world's leading breast cancer organization, today announced $26 million in funding for new research projects that focus on metastatic breast cancer, developing new, more-effective [...]

LOS ANGELES -- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) [...]

Treatment Targets Cancers Including Triple Negative Breast Cancer ST. PAUL, Minn. -- Today, Humanity Life Extension, LLC announced a breakthrough metastatic cancer treatment known as The Humility[R] Cancer Treatment. Doctors [...]

LOS ANGELES -- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for neratinib in [...]

WALTHAM, Mass. -- Minerva Biotechnologies, a biopharmaceutical company focused on developing immunotherapies for cancer and cellular therapies in regenerative medicine, announced today that the U.S. FDA (Food and Drug Administration) [...]

KEYTRUDA Now Approved for First-Line Treatment of Patients with Metastatic or with Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma as Monotherapy for Patients Whose Tumors Express PD-L1 (CPS 1) [...]

CAMBRIDGE, Mass. -- Foundation Medicine, Inc. today announced that new data informed by the use of its portfolio of comprehensive genomic profiling (CGP) tests will be presented at the 2019 [...]

Novel therascreen([R] ) FGFR RGQ RT-PCR Kit will aid in identifying patients eligible for treatment with BALVERSA ([TM] ) (erdafitinib), developed by Janssen GERMANTOWN, Md. & HILDEN, Germany -- QIAGEN [...]

KEYTRUDA Now Approved for First-Line Treatment of Patients with Stage III NSCLC Who Are Not Candidates for Surgical Resection or Definitive Chemoradiation, or Metastatic NSCLC, and Whose Tumors Express PD-L1 [...]

The broadcast will feature expert insights from industry experts in oncology CRANBURY, N.J. -- OncLive[R], the nation's leading digital resource focused on providing oncology professionals with the most current and [...]

- This Tecentriq combination is the first cancer immunotherapy regimen approved for breast cancer - - Triple-negative breast cancer is an aggressive disease, with high unmet medical need - SOUTH [...]

- Approval based on survival benefit of Tecentriq, in combination with Avastin, paclitaxel and carboplatin (chemotherapy), in people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or [...]

- Rebastinib is a Potent and Selective Inhibitor of the TIE2 kinase, the Receptor for Angiopoietins , an Important Family of Vascular Growth Factors in the Tumor Microenvironment - WALTHAM, [...]

Fourth Orphan Drug Designation in the U.S. for AstraZeneca and Merck's LYNPARZA KENILWORTH, N.J. -- AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced [...]

Approval Based on Results of KEYNOTE-189, Where KEYTRUDA in Combination with Pemetrexed and Platinum Chemotherapy Reduced the Risk of Death by Half Compared to Chemotherapy Alone KENILWORTH, N.J. -- Merck [...]

* Opdivo is now the first Immuno-Oncology treatment approved for small cell lung cancer (SCLC) patients who received platinum-based chemotherapy and at least one other line of therapy * Approval [...]

LOUISVILLE, Ky. -- Onco360, the nation's largest independent Oncology Pharmacy, announced today that it has been selected to participate in the limited distribution network for Array Biopharma's new products BRAFTOVI[TM] [...]

Results announced at the annual ASCO meeting on June 2, 2018 SCOTTSDALE, Ariz. -- Translational Drug Development (TD2)--an oncology-specialty CRO that guides medicines through the preclinical, regulatory and clinical trial [...]

SOUTH SAN FRANCISCO, Calif. -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the [...]

The FDA also granted the Opdivo plus Yervoy combination Breakthrough Therapy Designation for this potential indication PRINCETON, N.J. -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food [...]

CARY, N.C. -- Biologics, Inc., a McKesson Specialty Health oncology and complex care pharmacy services company, has been selected by the Janssen Pharmaceutical Companies of Johnson & Johnson1 to be [...]

* Advaxis reaches important regulatory milestone for axalimogene filolisbac with submission of Conditional MAA to treat metastatic cervical cancer in patients who progress beyond first-line therapy * The MAA submission [...]

FASLODEX in Combination with Abemaciclib Showed 16.4 Months of Progression-Free Survival (PFS) Second Approval in Three Months Expands Treatment Options for Women with HR+, HER2- Advanced Breast Cancer WILMINGTON, Del. [...]

TOKYO -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Genentech Inc., a member of the Roche Group, obtained approval from the U.S. Food and Drug Administration (FDA), for [...]

CARY, N.C. -- Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by Eli Lilly and Company to be in the limited distribution network for VERZENIO(TM) [...]

VILLEJUIF, France -- WIN Consortium (WIN) received the US Food and Drug Administration (FDA)'s approval to start the clinical investigation of a novel therapeutic approach using a combination of three [...]

MADISON, Wis. -- Madison Vaccines Incorporated (MVI) today announced the first patient has been dosed in an expanded clinical trial to further extend the potential benefits of checkpoint inhibitors to [...]

Conference call and webcast on Tuesday, March 28th at 14:30 pm CET/08:30 am EDT * Primary progression-free survival (PFS) and overall survival (OS) endpoints met in patients with low asparagine [...]