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Home
» Pipeline
Pipeline
July 9, 2018
Company
Drug/Device
Medical Condition
Status
Prana Biotechnology Ltd
PBT434
Parkinsonian diseases
Phase I trial initiated
Poxel SA
Imeglimin
Metabolic diseases, including type 2 diabetes and non-alcoholic steatohepatitis (NASH)
Phase III trial initiated enrolling 403 subjects in the U.S.
Cellerant Therapeutics, Inc.
romyelocel-L (human myeloid progenitor cells)
serious bacterial and fungal infections in patients with de novo acute myeloid leukemia (AML) undergoing induction chemotherapy
RMAT designation granted by the FDA
Merck & Company
KEYTRUDA in combination with carboplatin-paclitaxel or nab-paclitaxel
First-line treatment for metastatic squamous non-small cell lung cancer (NSCLC)
Priority Review granted for sBLA by the FDA
Merz Neurosciences
Xeomin (incobotulinumtoxinA)
chronic drooling in adults with neurodegenerative diseases
sBLA approved by the FDA
Compugen Ltd
COM701 (first-in-class immunioncology therapeutic antibody targeting PVRIG in patients
advanced solid tumors
IND clearance granted by the FDA
Elite Pharmaceuticals, Inc.
generic Percocet (Oxycodone Hydrochloride and Acetaminophen, USP CII)
management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
aNDA approval granted by the FDA
Acadia Pharmaceuticals Inc.
NUPLAZID (pimavanserin) capsule
Parkinson’s disease psychosis
Approval granted by the FDA
Pulmonx Inc.
Zephyr Endobronchial Valve (Zephyr Valve)
severe emphysema
Approval granted by the FDA
Dermira
Qbrexza
excessive underarm sweating due to primary axillary hyperhidrosis
Approval granted by the FDA
ReCor Medical
Paradise Ultrasound Denervation System
treatment of Hypertension
Approval granted by the FDA
Alkermes plc
Aristada Initio (aripiprazole lauroxil)
schizophrenia in adults
Approval granted by the FDA
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