Company

Product

Description

Indication

Status

DBV Technologies SA, of Montrouge, France

Viaskin Peanut

Allergen desensitizer

Peanut allergy

BLA submitted

Dynacure SAS, of Strasbourg, France

DYN-101

Antisense drug that modulates expression of dynamin 2

Centronuclear myopathies

FDA granted orphan designation

Evoke Pharma Inc., of Solana Beach, Calif.

Gimoti

Metoclopramide nasal spray

Diabetic gastroparesis

NDA to be resubmitted in the fourth quarter of 2019

G1 Therapeutics Inc., of Research Triangle Park, N.C.

Trilaciclib

Myelopreservation agent

Small-cell lung cancer

FDA granted breakthrough therapy designation

Gilead Sciences Inc., of Foster City, Calif.

Descovy

Emtricitabine 200-mg and tenofovir alafenamide 25-mg tablets

Reduction of risk of sexually acquired HIV infection in men and transgender women who have sex with men

FDA Antimicrobial Drugs Advisory Committee recommended approval 16-2

Helix Biopharma Corp., of Richmond Hill, Ontario

LDOS-47

Single domain antibody conjugated therapeutic

Metastatic pancreatic cancer

FDA approved phase Ib/II study with doxorubicin

Ziopharm Oncology Inc., of Boston

Ad-RTS-hIL-12 plus veledimex

Gene therapy to induce and control interleukin-12

Glioma

EMA Committee for Orphan Medicinal Products adopted a positive opinion recommending orphan designation


Notes

For more information about individual companies and/or products, see Cortellis.

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