" class="no-js "lang="en-US"> FDA Archives - Page 12 of 14 - Medtech Alert
Saturday, June 27, 2026

Sort by:

Date

Top Post

Experimental Cancer Drug May Slow Inflammation Linked to Heart Disease

An experimental drug already tested as a potential treatment for cancer, lung, and Alzheimer’s disease […]

Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for the Treatment of Primary Vitreoretinal Lymphoma

Aldeyra Therapeutics has announced the submission of a New Drug Application (NDA) to the US […]

Click Therapeutics Receives FDA Breakthrough Device Designation for Prescription Digital Therapeutic to Treat Episodic Migraine

Click Therapeutics, a leader in Digital Therapeutics™ as prescription medical treatments, has announced today that […]

FDA Approves Roche’s Evrysdi for Use in Babies Under Two Months With Spinal Muscular Atrophy (SMA)

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration […]

FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

Today, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) […]

FDA Approves NGS-Based Companion Diagnostic for EGFR Exon20 Insertion Mutant Non-Small Cell Lung Cancer Tumor Tissue

The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific‘s Oncomine Dx Target […]

FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia

Today, the U.S. Food and Drug Administration approved Rethymic for the treatment of pediatric patients […]

Roche Receives FDA Approval for First Companion Diagnostic to Identify dMMR Solid Tumour Patients Eligible for Anti-PD-1 Immunotherapy

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval […]

Tezepelumab Regulatory Submission Accepted and Granted FDA Priority Review in the US for the Treatment of Patients with Asthma

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for […]

FDA Approval of Aducanumab

Neurimmune welcomes the news that the U.S. Food and Drug Administration (FDA) has approved Biogen‘s […]

U.S. FDA Approves Prevnar 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved […]

  1. Eloxx Pharmaceuticals Announces Final Data Assessment from Phase 2 Combination Clinical Trial of ELX-02 in Class 1 Cystic Fibrosis Patients Read more
  2. Verge Genomics Announces Positive Safety and Tolerability Data from the Phase 1 Clinical Trial of VRG50635, a Potential Best-in-Class Therapeutic for All Forms of ALS Read more
  3. DEM BioPharma Appoints Wendy Young, Ph.D., to Scientific Advisory Board Read more
  4. Confo Therapeutics Enters into Research Collaboration for GPCR-Targeting Antibody Discovery with AbCellera Read more
  5. Vyriad Announces Expansion of T-Cell Lymphoma Trial at Mayo Clinic Read more