Tuesday, August 18, 2026

U.S. FDA Grants Full Approval of Kite’s Tecartus for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma

›
The U.S. Food and Drug Administration (FDA) has granted traditional (full) approval to Kite’s CAR T-cell therapy, Tecartus (brexucabtagene a...
Monday, August 17, 2026

FDA Approves Revtorpyk (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer

›
Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor ...
Friday, August 14, 2026

FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer

›
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced  the U.S. Food and Drug Administration (FDA)  acceptance of  ...
Thursday, August 13, 2026

Xspray Pharma Re-Submits its FDA Application for Dasynoc

›
Xspray Pharma AB (publ) has re-submitted its application for market approval for Dasynoc® to the U.S. Food and Drug Administration (FDA). Da...
Monday, August 10, 2026

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara) Brain Cancer Imaging Candidate

›
Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) announced the resubmission of a New Drug Application (NDA) to the United Stat...
Wednesday, August 5, 2026

Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-Positive NSCLC

›
Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically pr...
Monday, August 3, 2026

Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease

›
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies desi...
Saturday, August 1, 2026

Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)

›
Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases,...
Thursday, July 30, 2026

Nanomedicine offers targeted solutions for breast cancer treatment

›
Breast cancer (BCA) is one of the most common cancers worldwide, with high mortality and morbidity in women. This review focuses on the appl...
Wednesday, July 29, 2026

Metformin mimics exercise-related metabolic effects in prostate cancer patients

›
In continuation of my update on   metformin A new study has found that metformin, a widely prescribed diabetes drug, may mimic one of exerci...
Tuesday, July 28, 2026

FDA Approves Komzifti (ziftomenib) for the Treatment of Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

›
Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151)  announced the U.S. Food and Drug Administration (FDA)   approval o...
Saturday, July 25, 2026

FDA Grants Accelerated Approval to Hyrnuo (sevabertinib) for Non-Squamous Non-Small Cell Lung Cancer

›
Following Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has granted accelerated approval...
Friday, July 24, 2026

FDA Approves Cardamyst (etripamil) Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia

›
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) announced  the U.S. Food and Drug Administration (FDA) approved its first commercial product, ...
Thursday, July 23, 2026

FDA Approves Nuzolvence (zoliflodacin) for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents

›
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA),   announced   the U.S. Food and Drug Administration (FDA)  a...
Wednesday, July 22, 2026

FDA Approves Myqorzo (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

›
Cytokinetics, Incorporated (Nasdaq: CYTK) announced the U.S. Food and Drug Administration (FDA) approval of  Myqorzo™ (aficamten, 5 mg, 10 m...