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Next-Generation Peanut Allergy Therapy Earns FDA Fast Track Designation

The FDA has granted Fast Track designation to PVX108, Aravax’s peptide-based immunotherapy designed to treat peanut allergy with fewer treatment-related reactions. The post Next-Ge...

FDA Grants Fast Track Designation to ETX-19477 in BRCA-Mutated HR+/HER2– Breast Cancer

From: .onclive.com The FDA has granted fast track designation to ETX-19477 for the treatment of adult patients with BRCA-mutated, hormone receptor (HR)–positive, HER2-negative unre...

Consano Bio Receives FDA Fast Track Designation for C-1101 in Chronic, Painful Lumbosacral Radiculopathy (LSR) or Chroni...

Designation follows recent FDA clearance of the Company's IND application for C-1101, an investigational, potentially disease-modifying non-opioid biologic for chronic sciatica.

<![CDATA[FDA Grants Accelerated Approval to Tudriqev in Combination with Nivoumab for Advanced Melanoma]]>

FDA backs faster development path for Parkinson’s cell therapy

The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to sasineprocel (ANPD001), an experimental cell therapy to treat P...

FDA fast-tracks experimental vaccine aiming to slow early Parkinson’s

The U.S. Food and Drug Administration (FDA) has awarded fast-track designation — a status that aims to speed the development of promising treatments for serious conditions — to a S...

Ready to use Parkinson’s stem cell therapy put on FDA fast track

An off-the-shelf, or ready to use, stem cell therapy that’s designed to replace the nerve cells lost in Parkinson’s disease and restore neurological function has been put on a deve...

<![CDATA[FDA Approves Daraxonrasib as First-in-Class Targeted Therapy for Metastatic Pancreatic Cancer]]>

<![CDATA[FDA Grants Accelerated Approval to Zenbexus Plus Daratumumab and Hyaluronidase-fihj and Dexamethasone for Mu...

<![CDATA[FDA Clears Consano’s IND for C-1101 ]]>

FDA’s Expedited IND Pilot Comes Into Focus

By Sarah Wicks —

Protagenic Therapeutics Receives FDA Pre-IND Feedback Supporting New IND for PT00114 in Generalized Anxiety Disorder

FDA raises no objection to the Company's planned Phase 1 program design, dose-escalation approach, or CMC and nonclinical packages; IND submission remains on track for the fourth q...

Revolution drug heralded as a pancreatic cancer breakthrough cleared by FDA

Rasonque’s speedy approval — just a month after a completed submission — represents a paradigm shift for a notoriously deadly cancer and begins what analysts see as a highly lucrat...

<![CDATA[FDA Approves Otsuka’s First-In-Class Simtriyo for Adults & Pediatric Patients ]]>

<![CDATA[FDA Approves Revtorpyk for Treatment of Advanced HR-Positive, HER2-Negative Breast Cancer ]]>

<![CDATA[FDA Issues CRL to Elevar Therpaeutics for Combination of Rivoceranib and Camrelizumab ]]>

FDA approves AstraZeneca’s Etcamah, opening ctDNA-guided treatment paradigm in breast cancer

In a rare divergence from its own expert panel, the FDA has granted accelerated approval to AstraZeneca’s camizestrant, turning a contentious regulatory review into a landmark win...

New Melanoma Drug, Tudriqev, Based On Herpes Virus Granted FDA Accelerated Approval

MONDAY, Aug. 10, 2026 — Federal regulators have granted accelerated approval to a novel therapy for advanced melanoma — giving doctors another weapon to fight this challenging skin...

FDA greenlights Revolution Medicines' pancreatic cancer gamechanger

Following dynamite data that earned a standing ovation at the American Society of Clinical Oncology meeting in May, Revolution Medicines’ Ras inhibitor daraxonrasib has been approv...

Recovery for Replimune: Accelerated Approval for Cancer Drug Twice Spurned by FDA

Replimune went from an FDA rejection to a resubmission, a positive advisory committee vote, and finally an accelerated regulatory approval for advanced melanoma — all in less than...

<![CDATA[FDA Approves Fabhalta to Slow Kidney Function Decline in Primary IgAN in Adults ]]>

FDA approves breakthrough cancer drug months ahead of schedule: ‘Unprecedented results’

The FDA approved the medication more than six months ahead of schedule after trials showed it nearly doubled median survival to 13.2 months versus 6.7 months with chemotherapy.

<![CDATA[FDA Approves Leqembi Iqlik Subcutaneous Injection for Early Alzheimer’s Disease]]>

FDA Eases Approval Path for Certain Cancer Companion Diagnostic Tests

The U.S. Food and Drug Administration has issued a final order moving certain laboratory tests used to help guide treatment with approved cancer drugs from...