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Home
  • About
    • About the Navigator
    • Navigator FAQs
  • Guides
    • For Patients and Caregivers
    • For Physicians and Healthcare Providers
    • For Companies and Sponsors
  • Company Directory
    • View Company Directory
    • Submit Company Information
  • Resources
  • Expanded Access eRequest

Expanded Access Listings

You can search in free text – simply type the disease, drug, company name, or other detail into the Search bar below and click Apply
Displaying 420 of 421

Neuraptive Therapeutics Inc.

NTX-001 to Repair Peripheral Nerve Transection(s)

Conditions: Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves

The proposed use of NTX-001 for transections of upper extremity and facial peripheralnerves, acutely or planned.

Matrix Biomed, Inc.

Treatment of Metastatic Cancer in Terminally Diagnosed Patients

Conditions: Metastatic Cancer

The objective is to provide terminally diagnosed patients with a last line of treatmentwhile improving overall quality of life. Tempol can be added to any chemotherapy regimento potentially reduce side effects and overcome chemoresistance.

DBV Technologies

Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children

Conditions: Peanut Allergy

This is an open label expanded access program for male and female patients 2 years orolder, to provide continued desensitization treatment with DBV712 250 mcg.

Clene Nanomedicine

Two Intermediate Expanded Access Protocols (EAP) CNMAu8.EAP01 and CNMAu8.EAP02 for ALS

Conditions: Amyotrophic Lateral Sclerosis

The primary objective of the intermediate expanded access protocol is to provide accessto the investigational product, CNM-Au8, to up to 300 people living with ALS (pALS).No formal clinical hypotheses are being evaluated with concurrent controls.Secondary objectives include assessment of the safety of CNM-Au8 treatment in pALS.Safety will be assessed through the frequency of serious adverse events (SAEs),treatment-emergent adverse events (TEAEs) assessed as 'severe', discontinuations due toTEAEs, and laboratory abnormalities assessed as clinically significant during routineclinical monitoring (as applicable).

Bristol-Myers Squibb

Expanded Access for Apixaban

Conditions:

This is an expanded access designed to provide access to apixaban for eligibleparticipants.

Celcuity Inc

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Conditions: Breast Neoplasm Malignant Female

Continued access to treatment for subjects who continue benefit from therapy withgedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Ellodi Pharmaceuticals, LP

Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Conditions: Eosinophilic Esophagitis

This expanded access program is an open-label, single-arm design where consentingpatients may participate up until APT-1011 is commercially available in the relevantregions or the protocol is terminated by the Sponsor.

Novo Nordisk A/S

Compassionate Use of Concizumab if You Have Haemophilia

Conditions: Congenital Haemophilia

The compassionate use programme will give participants concizumab for free, even thoughit is not yet approved by health authorities. This is because participants need thismedicine to treat their haemophilia properly. The programme will check that participantsare safe and that the medicine works for them. The programme may last for years.Participants will take one injection under their skin every day. Participants will have4-5 visits with the study doctor for the first half year. After that they will have 1visit every half year. At all clinic visits participants will have blood samples taken.Participants will fill in a diary between the visits.A patient is considered to have completed the programme when any of the followingcriteria occurred first: 1) when the patient is included in a clinical trial withconcizumab or 2) up to 6 months after concizumab is commercially available in thepatient's country and approved for the patient (The time span of 6 months should provideample time for the patient to obtain concizumab commercially) or 3) the sponsor decidesto discontinue concizumab clinical development for the patient's population.

Cook MyoSite

Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)

Conditions:

This is an expanded access program (EAP) for eligible participants designed to provideaccess to autologous muscle derived cells (AMDCs). Treating physicians may submitrequests for expanded access to Cook MyoSite's investigational product by email toMYO-ExpandedAccess@CookMyoSite.com.

Chimerix

Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas

Conditions: Glioma, H3 K27M

This is an intermediate-size expanded access protocol to provide ONC201 (dordaviprone) topatients with H3 K27M-mutant and/or midline gliomas who cannot access ONC201(dordaviprone) through clinical trials.

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© Reagan-Udall Foundation for the FDA