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Latest MedTech News for CereVasc and Nanopath
CereVasc’s eShunt System Study; FDA Approves NGS-Based CDx for Trastuzumab Deruxtecan; Nanopath Secures $10 Million Funding; BD, Accelerate Diagnostics Announce Collaboration; Avails Medical’s Clinical Trials for eQUANT; Movano Ring Exceeds Accuracy Targets for SpO2 & Heart Rate Monitoring

CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System On August 09, 2022, CereVasc, Inc., a privately held, clinical-stage medical device company developing novel, minimally invasive treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved ...

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Pharma News for Novartis and Gilead
Novartis’ Canakinumab for NSCLC; Novartis’s Zolgensma Updates; Trodelvy Prospects in New Breast Cancer Use; Novartis Secures European Approval For Pluvicto; Bristol-Myers Squibb’s Abecma Phase III Trials; Trastuzumab Approved for Deruxtecan for HER2-Mutant NSCLC

Novartis’ Canakinumab Fails in Phase III Trials for NSCLC Canakinumab's prospects as an anticancer therapy were already dwindling when a third phase III trial in non-small cell lung cancer (NSCLC) failed to reach its objectives. The most recent setback came from the CANOPY-A study, which included patients with N...

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Pharma News for Sanofi, Bayer, Spero
AstraZeneca’s Imfinzi Shows Positive Results; Novartis Announces Results of Tislelizumab; FDA Grants Orphan Drug Designation to Evorpacept; EU Approves Sanofi’s Xenpozyme; Bayer’s Kerendia Approves in China; FDA Breakthrough Therapy Designation to Talquetamab; FDA Puts Clinical Hold on Sanofi’s Tolebrutinib; FDA Rejects Spero’s Tebipenem

FDA Grants Orphan Drug Designation to Evorpacept for AML ALX Oncology Holdings announced that the U.S. Food and Drug Administration had granted orphan drug designation to Evorpacept, a next-generation CD47 blocker, for treating patients with acute myeloid leukemia (AML). Acute Myeloid Leukemia (AML) is an agg...

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Pharma News and Updates for GSK, Roche, and Owkin
GSK’s RSV Vaccine Clears Phase III Test in Adults; Roche’s Tecentriq for Adjuvant NSCLC; Owkin Bags $ 180 million from BMS; EU Approves Roche’s Mosunetuzumab; Dostarlimab Elicits Clinical Complete Response in dMMR Rectal Cancer; FDA Backs Bluebird’s CALD Gene Therapy; Takeda’s Dengue Fever Vaccine TAK-003; FDA Approves Dupilumab

GSK Starts Preparations for Regulatory Filings as RSV Vaccine Clears Phase III Test in Adults GSK plans to initiate preparation for regulatory submissions for its respiratory syncytial virus (RSV) vaccine after the vaccine performed well in the much-anticipated AReSVi 006 trial in individuals aged 60 and above.&...

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Pharma News and Updates for BMS, Mirati, Roche, Dermavant, Merck
Bristol-Myers Squibb’s Opdivo Approval; Mirati’s KRAS-inhibitor Adagrasib; J&J and Legend Biotech’s CAR-T Carvykti Approval; Roche’s Glofitamab; Arena Pharma’s Etrasimod Phase 3 Trials; FDA Approves Dermavant’s Vtama; FDA Approves Novartis’ Cell Therapy; NICE Approves Merck’s Keytruda

Bristol-Myers Squibb’s Opdivo Gets FDA Approval for Esophageal Cancer The FDA has approved two combination drug regimens based on Bristol-Myers Squibb’s PD-1 inhibitor Opdivo for previously untreated advanced Esophageal Cancer, encroaching on the territory belonging to Merck & Co’s rival Keytruda. The latest...

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Pharma News and Updates for Sanofi ViiV Argenx Novartis UCB Kyowa
Sanofi’s Rare Disease Drug Xenpozyme’ Approval; FDA Approves Novartis’ Pluvicto; AstraZeneca’s Imfinzi Trial Result; FDA’s Green Signal to Argenx’ Vyvgart; ViiV Healthcare and J&J’s HIV Treatment Cabenuva; UCB’s FINTEPLA Approval; Cullinan’s Update for CLN-081; MEI Pharma & Kyowa’s Zandelisib Approval

Sanofi’s Rare Disease Drug Xenpozyme Wins World’s First Approval in Japan Sanofi’s Xenpozyme, also known as olipudase alfa, the world's first therapy for the rare disease Niemann-Pick type A/B and B, has been approved for the treatment of children and adults with non-CNS manifestations of Acid Sphingomyelinase D...

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Pharma News and Updates for BMS, Biogen, Merck, Moderna, and Takeda
Bristol Myers’ Opdivo combo Opdualag for Melanoma; Biogen’s Aduhelm; Marinus’ Ztalmy for CDKL-5 Deficiency Disorder; Merck’s Keytruda + Lynparza; Vitaris’s Breyna; Moderna’s Second COVID-19 Booster Shot; Takeda’s Exkivity; BMS’s First LAG-3 Checkpoint Inhibitor

NHS Grants Fast Track Access to Takeda’s Exkivity Takeda has secured UK approval for its lung cancer therapy Exkivity, with an NHS access deal that could see it prescribed to patients within the next few weeks. The Medicines and Healthcare products Regulatory Agency has granted conditional marketing authorisa...

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pharma-news-for-pfizer-lilly-innovent-bayer-gsk-daewon
Pfizer & Lilly’s JAK Inhibitors Drug; FDA Approves Lilly’s Bebtelovimab; GSK’s Benlysta; Daewon’s Non-steroidal Anti-inflammatory Drug; Lilly & Innovent’s Lung Cancer Drug; Bayer’s Asundexian

Pfizer and Lilly's JAK Inhibitors Safety Concerns Prompt Europe to Investigate the Drug Class The risk of heart problems associated with the use of JAK inhibitors has called the entire drug class into question. In September, the FDA announced that it would require safety warnings for drugs such as Pfizer's Xelja...

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oncological-drugs-to-be-launch-in-2022
Most Promising Oncological Drugs Expected to Launch in 2022

The innovation in the oncology drug pipeline has resulted in a record number of FDA and EU approvals in recent years, as investigators and sponsors seek new and targeted treatments for individuals diagnosed with different types of cancers each year. In 2022, regulators will continue to evaluate new oncology therapi...

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pharma-news-for-noxxon-nuvalent-stryker-exact-sciences
Noxxon’s NOX-A12 clinical trial; Exact Sciences buys PreventionGenetics; Nuvalent’s clinical trails for NVL-520; Stryker acquires Vocera Communications

Noxxon continues enrolment in a glioblastoma therapy trial Noxxon Pharma continues subject enrolment in the GLORIA clinical trial of NOX-A12 in brain cancer (glioblastoma) patients. The move comes after the Data Safety Monitoring Board (DSMB) evaluated safety results from the preliminary four-week treatment with...

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