Gastric cancer
Jul 15, 2025
Nanoscope’s MCO-010 Begins FDA Rolling Submission for Retinitis Pigmentosa; Bayer’s KERENDIA Approved by FDA for Heart Failure With Preserved Ejection Fraction; Klotho Neurosciences’ KLTO-202 Receives FDA Orphan Drug Designation for ALS; Trethera’s TRE-515 Granted FDA Fast Track Designation for Metastatic Prostate Cancer; Adcentrx’s ADRX-0405 Awarded FDA Orphan Drug Designation for Gastric Cancer
Nanoscope Therapeutics Begins FDA Rolling Submission for MCO-010 in Retinitis Pigmentosa Nanoscope Therapeutics has initiated a rolling submission of its Biologics License Application (BLA) to the FDA for MCO-010, a first-in-class, gene-agnostic optogenetic therapy targeting severe vision loss due to retinitis p...
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May 09, 2025
ENHERTU’s Rapid Rise: How the HER2-Targeting ADC Is Redefining Cancer Treatment with Back-to-Back Label Expansions
ENHERTU, a next-generation antibody-drug conjugate (ADC) jointly developed by Daiichi Sankyo/ AstraZeneca since March 2019, except in Japan, where Daiichi Sankyo maintains exclusive rights. It is worth noting that recently, in November 2024, Daiichi Sankyo and AstraZeneca were awarded the Galien Foundation 2024 Pri...
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Feb 25, 2025
CTEXLI Approved for Cerebrotendinous Xanthomatosis; SIGX1094 Wins Fast Track for Diffuse Gastric Cancer; Bavarian Nordic’s Chikungunya Vaccine Cleared for Ages 12+; UX111 Gene Therapy Gains Priority Review for Sanfilippo Syndrome; SUBLOCADE Label Update Approved
FDA Approves CTEXLI, the First-Ever Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disorder Mirum Pharmaceuticals, Inc. announced that the FDA has approved CTEXLI (chenodiol) tablets as the first and only treatment for cerebrotendinous xanthomatosis (CTX), a rare, progressive, and debilitatin...
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Oct 02, 2024
Gastrointestinal Cancers: Exploring the Range of Digestive Tract Malignancies
With millions of cases diagnosed globally each year, gastrointestinal cancers represent a significant health challenge but also an opportunity for breakthroughs in targeted therapies and personalized medicine. Gastrointestinal cancers refer to a group of cancers that affect the digestive system, including the esoph...
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Jun 04, 2024
Moderna’s mRESVIA(R) FDA Approval; Novartis Scemblix® Phase III Data; Kite’s Tecartus for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia; Astellas’ Zolbetuximab Biologics License Application; CHMP Recommends AstraZeneca’s Tagrisso
FDA Greenlights Moderna's RSV Vaccine mRESVIA(R) Moderna, Inc. has announced that the FDA has approved mRESVIA (mRNA-1345), an mRNA-based vaccine for respiratory syncytial virus (RSV), to protect adults aged 60 and over from lower respiratory tract infections caused by RSV. This approval, granted under a breakth...
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Jan 31, 2023
Eli Lilly’s Jaypirca Approval; Novartis’ Adakveo EMA Review; Janssen’s CARTITUDE-4 Study of CARVYKTI; Negative Review on Ipsen’s Palovarotene; Gilead Sciences and Kite’s Yescarta NICE Recommendations; Daiichi Sankyo and AstraZeneca’s Enhertu EU Approval
FDA Approves Eli Lilly’s Jaypirca for Relapsed Mantle Cell Lymphoma Eli Lilly has received FDA approval for Jaypirca, a non-covalent BTK inhibitor, in relapsed mantle cell lymphoma (MCL) patients who have relapsed after treatment with other drugs in the class. Adult MCL patients who have previously received at l...
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Jun 23, 2022
CE Mark to Ibex’s Gastric Cancer Detection System; Senseonics’s Eversense E3 Continuous Glucose Monitoring System; NEUSPERA’s NUVELLA SYSTEM; Conformal Medical Initiates CONFORM Pivotal Trial; Meridian Launches New qPCR Master Mixes for Stool Samples; Sentinel Diagnostics Launches SENTiFIT 800
Conformal Medical Announces Launch of CONFORM Pivotal Trial On June 17, 2022, Conformal Medical Inc, is a medical device company manufacturing devices to avoid strokes in patients with non-valvular atrial fibrillation and developing next-generation LAAO technology. Its exclusive technology is intended to make le...
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May 24, 2022
PTC Therapeutics’ Gene Therapy Upstaza; Sanofi and Regeneron’s Dupixent; Bayer CAR-T Collaboration with Atara; FDA Accepts Biohaven’s Zavegepant; AbbVie Files FDA Approval for ABBV-951; Innoviva to Acquire Entasis; FDA Orphan Drug Designation to XMT-2056; FDA Approves Azacitidine for Juvenile Myelomonocytic Leukemia
EU Recommends Approval for PTC Therapeutics’ Gene Therapy Upstaza Upstaza, a gene therapy developed by PTC Therapeutics for patients with the genetic condition AADC deficiency, has been recommended for EU approval, putting another test of gene therapy's commercial prospects in the union. Upstaza (eladocagene exu...
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Apr 26, 2022
Coherus Biosciences’ Toripalimab; Keymed’s CMG901; Biogen Alzheimer’s Drug Aduhelm; Vicore’s Digital Therapeutics Study; Cassiopea’s Acne Treatment Winlevi; Samsung Biologics Acquires Samsung Bioepis; Roche’s Giredestrant; Ashai Kasei Acquires Bionova
FDA Grants Orphan Drug Designation to Coherus Biosciences’ Toripalimab for Small Cell Lung Cancer The FDA granted orphan drug status to Coherus Biosciences’ Toripalimab (TuoYi) based on data from the phase 3 JUPITER-08 study in patients with extensive-stage Small-cell Lung Cancer (ES-SCLC). Patients in the curre...
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Jan 18, 2022
Algernon’s NP-120 (ifenprodil); Pieris’s cinrebafusp alfa (PRS-343) clinical trial; Gaumard Scientific’s multidisciplinary patient simulator HAL S5301; Hekka Labs’s decentralized healthcare ecosystem
Algernon receives positive FDA feedback on Phase IIb chronic cough trial The US Food and Drug Administration (FDA) has given positive feedback for Algernon Pharmaceuticals’ Phase IIb clinical trial of NP-120 (ifenprodil) for chronic cough treatment. A receptor antagonist of N-methyl-D-aspartate (NMDA), ifenp...
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