| Company |
Trade Name |
Generic Name |
Action |
|
Abeona Therapeutics Inc.
|
ABO-202 |
|
FDA granted orphan drug designation for the treatment of infantile Batten disease.
|
| Agios Pharmaceuticals Inc. |
Ivosidenib/AG-120 |
|
FDA accepted new drug application and granted priority review for the treatment of patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 1 mutation.
|
|
Allergan plc
|
Avycaz |
ceftazidime and avibactam |
FDA approved supplemental new drug application for the treatment of patients with hospital-acquired and ventilator-associated bacterial pneumonia.
|
|
Amicus Therapeutics
|
Migalastat HCI |
migalastat |
FDA accepted new drug application for the treatment of T-cell lymphoma.
|
| Arrowhead Pharmaceuticals Inc. |
ARO-AAT |
|
FDA granted orphan drug designation for the treatment of a rare genetic liver disease associated with alpha-1 antitrypsin deficiency.
|
|
AstraZeneca and Merck
|
|
selumetinib |
FDA granted orphan drug designation for the treatment of neurofibromatosis type 1.
|
|
Ferring Pharmaceuticals Inc.
|
Zomacton
|
somatropin |
FDA approved Zomacton, a recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.
|
| GamaMabs Pharma |
GM102
|
|
FDA granted orphan drug designation for the treatment of cancers.
|
| Hansa Medical |
IdeS
|
|
FDA granted orphan drug designation for the treatment of Guillain-Barré syndrome.
|
|
Icon Bioscience, Inc.
|
Dexycu
|
dexamethasone intraocular suspension |
FDA approved Dexycu for the treatment of inflammation associated with cataract surgery.
|
| Janssen Pharmaceutical Co. |
Erlead
|
apalutamide |
FDA approved Erlead for the treatment of patients with prostate cancer that has not spread (nonmetastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant).
|
|
Pacira Pharmaceuticals Inc.
|
Exparel
|
bupivacaine liposome injectable suspension |
FDA Anesthetic and Analgesic Drug Products Advisory Committee voted against approval for use as a nerve block to produce regional analgesia.
|
| Pfizer Inc. |
PF-04965842 |
|
FDA granted breakthrough therapy designation for the treatment of patients with moderate-to-severe atopic dermatitis.
|
| Prometic Life Sciences Inc. |
|
Inter-Alpha-Inhibitor-Proteins |
FDA granted orphan drug designation for the treatment of necrotizing enterocolitis.
|
| Sandoz |
Glatopa
|
glatiramer acetate injection 40 mg/mL |
FDA approved generic version of Copaxone by Teva Neuroscience Inc. for a three times-a-week therapy for relapsing forms of multiple sclerosis.
|
| SciTech Development |
ST-001
|
|
FDA granted orphan drug designation for the treatment of T-cell lymphoma.
|
| Vertex Pharmaceuticals |
Symdeko
|
tezacaftor/ivacaftor and ivacaftor |
FDA approved Symdeko for the treatment of the underlying cause of cystic fibrosis in patients aged ≥12 years who have two copies of the F308del mutation in the cystic fibrosis transmembrane conductance regulator gene or who have ≥ one mutation that is responsive to tezacaftor/ivacaftor.
|