Pipeline

New Pipeline from BioSight,Vidac Pharma, Zebra Medical Vision and Kolon TissueGene

July 16, 2018

Company Drug/Device Medical Condition Status
OncoNano Medicine ONM-100 intraoperative imaging agent tumor acidosis for the detection of solid tumors Phase I trial initiated enrolling subjects in The Netherlands
BELLUS Health Inc. BLU-5937 chronic cough Phase I trial initiated enrolling 90 subjects in the U.S.
Aeromics, Inc. AER-271 cerebral edema Phase I trial initiated enrolling 78 healthy subjects in the U.S.
Tetra Discovery Partners BPN14770 Fragile X Syndrome Phase II trial initiated enrolling 30 adult male subjects, ages 18-45 years, in the U.S.
BioSight Ltd. BST-236 Newly-diagnosed Acute Myeloid Leukemia (AML) patients, either de novo or secondary to myelodys-plastic disorder (MDS) who are unfit for standard chemotherapy due to its severe toxicity Phase IIb trial initiated enrolling subjects in 25 medical centers in the U.S. and Israel
Vidac Pharma VDA-1102 Actinic Keratosis (AK) Phase IIb trial initiated enrolling 150 subjects in the U.S.
Citius Pharmaceuticals, Inc. Mino-Lok therapy in combination with systemic antibiotics Catheter Related Bloodstream Infections (CRBSIs) Phase III trial initiated enrolling 700 subjects in the U.S.
Kolon TissueGene, Inc. Invossa knee osteoarthritis (OA) Phase III trial initiated enrolling 1,020 subjects in the U.S.
Recursion REC-994 cerebral cavernous malformation (CCM) IND clearance granted by the FDA
Adagene, Inc. ADG-106 advanced solid tumors and non-Hodgkin lymphoma IND clearance granted by the FDA
Bausch + Lomb Loteprednol etabonate ophthalmic gel management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate NDA approval granted by the FDA
Zebra Medical Vision Coronary Calcium Scoring algorithm coronary artery disease (CAD) 510(k) clearance granted by the FDA
OCULOCARE medical Inc. Alleye mobile medical software application indicated for the detection and monitoring of age-related macular degeneration (AMD) 510(k) clearance granted by the FDA
Eagle Pharmaceuticals, Inc. BENDEKA (bendamustine hydrochloride injection, or bendamustine HCI) chronic lymphocytic leukemia Orphan Drug Exclusivity (ODE) granted by the FDA
OBI Pharma Inc. OBI-3424 Treatment of Hepatocellular Carcinoma (HCC) Orphan Drug Designation granted by the FDA
US WorldMeds, LLC LUCEMYRA (lofexidine) tablets First non-opioid medication indicated for mitigation of opioid with-drawal symptoms to facilitate abrupt opioid discontinuation
in adults
Approval granted by the FDA

New Pipeline from Prana, Poxel, Cellerant and Merck & Company

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

New Pipeline from Glaukos, Oramed, Navitor and BioAtla

July 2, 2018

Company Drug/Device Medical Condition Status
Oramed Pharmaceuticals Inc. ORMD-0801 type 1 diabetes Phase I trial initiated
Erimos Pharmaceuticals, LLC terameprocol (EM-1421) High Grade Glioma (Grade III or IV) Phase I trial initiated
BioGend Therapeutics one-step autologous knee cartilage repair/regeneration repair treatment for knee chondral or osteochondral defects Phase I trial initiated enrolling 92 subjects
Rigel Pharmaceuticals, Inc. R835 (IRAK1/4 inhibitor) autoimmune and inflammatory diseases Phase I trial initiated enrolling 91 subjects
Navitor Pharmaceuticals, Inc. NV-5138 treatment-resistant depression (TRD) Phase I trial initiated enrolling 88 subjects
Axonics Modulation Technologies, Inc. rechargeable Sacral Neuromodulation (r-SNM) System urinary and bowel disfunction Phase I trial initiated enrolling 120 subjects
BioAtla, LLC BA3021 (CAB-ROR2-ADC therapeutic) advanced solid tumors including non-small cell lung cancer (NSCLC), triple negative breast cancer and soft tissue sarcoma Phase I/II trial initiated
Roche and Genentech TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and etoposide) Extensive-stage small cell lung cancer (ES-SCLC) Phase III trial initiated enrolling 403 subjects in the U.S.
Beckman Coulter Diagnostics Access hsTnl (high-sensitivity troponin assay) myocardial infarction 510(k) Clearance granted by the FDA
Renovis Surgical Technologies, Inc. Tesera SA Hyperlordotic ALIF Interbody Spinal Fusion System spinal fusion 510(k) Clearance granted by the FDA
Genentech Baloxavir marboxil single-dose oral flu treatment for people 12 years and older Priority Review and NDA approval granted by the FDA
Merck & Company KEYTRUDA (pembrolizumab) adjuvant therapy in advanced melanoma sBLA accepted by the FDA
Glaukos Corporation iStent inject Trabecular Micro-Bypass System reduction of intraocular pressure (IOP) in adult mild-to-moderate primary open-angle glaucoma (POAG) patients undergoing concomitant cataract surgery Approval granted by the FDA
Ferring Pharmaceuticals Inc. NOCDURNA (desmopressin acetate) treatment of nocturne due to nocturnal polyuria in adults who awaken at least two times per night to void Approval granted by the FDA
Achaogen Zemdri (plazomicin) complicated urinary tract infection Approval granted by the FDA
Array BioPharma, Inc. Braftovi + Mektovi BRAF-mutant metastatic melanoma Approval granted by the FDA
Processa Pharmaceuticals, Inc. PCS499 Necrobiosis Lipoidica (NL) Orphan Drug Designation granted by the FDA

New Pipeline from Grifols, Bay Labs, Avedro and TransMed7

June 25, 2018

Company Drug/Device Medical Condition Status
bluebird bio, Inc. LentiGlobin anemia Phase I trial
Kiyatec, Inc. Ex Vivo 3D (EV3D) cancer patients with both newly diagnosed and recurrent epithelial ovarian cancer and recurrent high-grade gliomas, which include glioblastomas (GBM) Phase I trial initiated enrolling 640 subjects
Arrowhead Pharmaceuticals, Inc. ARO-AAT subcutaneously administered RNA Interference (RNAi) therapeutic are genetic liver disease associated with alpha-1 antitrypsin deficiency Phase I trial initiated enrolling 44 subjects
Cambium Medical Technologies Elate Ocular topical fibrinogen-depleted human platelet lysate biologic dry eye secondary to graft-versus-host disease Phase I/II trial initiated
Cefaly Technology Cefaly ACUTE medical device acute treatment of migraine Phase III trial initiated enrolling 309 subjects in the U.S.
Avedro, Inc. epithelium-on (epi-on) corneal collage cross-linking procedure progressive keratoconus Phase III trial initiated enrolling 275 subjects with progressive keratoconus across approximately 20 sites in the U.S.
TransMed7, LLC SpeedBird platform of soft tissue biopsy devices soft tissue samples 510(k) Clearance granted by the FDA
Bay Labs EchoMD AutoEF software fully automated clip selection and calculation of left ventricular ejection fraction (EF) 510(k) Clearance granted by the FDA
LivaNova PLC MEMO 4D semi-rigid mitral annuloplasty ring mitral regurgitation (MR) 510(k) Clearance granted by the FDA
PerkinElmer, Inc. EUROIMMUN Crithidia luciliae systemic lupus erythematosus (SLE) 510(k) clearance granted by the FDA
BlueWind Medical RENOVA iStim implantable Tibial Nerve Neuromodulation System overactive bladder (OAB) Approval granted by the FDA
Grifols Procleix Ultrio Elite blood screening assay Approval granted by the FDA
Grifols Procleix WNV blood screening assay Approval granted by the FDA
Caladrius Biosciences, Inc. CD34+ cell therapy program refractory angina RMAT designation granted by the FDA
ImmunoGen, Inc. mirvetuximab soravtansine medium-to-high folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer Fast Track Designation granted by the FDA

New Pipeline from Roche, Genentech, Allergan and AMO Pharma

June 18, 2018

Company Drug/Device Medical Condition Status
Alnylam lumasiran Primary Hyperoxaluria Type 1 (PH1) Phase I trial initiated enrolling 25 patients with PH1
Cynata Therapeutics CYP-001 steroid-resistant acute graft-versus-host disease (GvHD) Phase I trial initiated enrolling 8 patients with steroid-resistant acute GvHD
Vizuri Health Sciences VZU00025 osteoarthritis Phase II trial initiated
NeuroRx NRX-101 suicidal bipolar depression Phase IIb/III trial initiated enrolling 12 patients
Allergan atogepant episodic migraine pain Phase IIb/III trial initiated enrolling 795 patients
icotec AG BlackArmor Carbon/PEEK Interbody Cages adults and children with hemophilia A without factor VIII inhibitors 510(k) Clearance granted by the FDA
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA assay Lyme disease bacteria 510(k) clearance granted by the FDA
AbbVie and Roche Venclexta in combination with Rituxan (rituximab) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Approval granted by the FDA
Genentech Rituxan (rituximab) moderate to severe pemphigus vulgaris (PV) Approval granted by the FDA
Fujirebio Diagnostics Lumipulse G B•R•A•H•M•S PCT Assay bacterial infections Clearance granted by the FDA
DyAnsys Drug Relief reduce the symptoms of opioid withdrawal without narcotics Clearance granted by the FDA
Arcus Biosciences AB928 breast and gynecologic malignancies Clearance granted by the FDA
Nordic Nanovector Betalutin relapsed or refractory follicular lymphoma (FL) Fast Track Designation granted by the FDA
Ironwood Pharma olinciguat (IW-1701) sickle cell disease Orphan Drug Designation granted by the FDA
AMO Pharma AMO-04 Rett Syndrome Orphan Drug Designation granted by the FDA
Samus Therapeutics PU-H71 myelofibrosis Orphan Drug Designation granted by the FDA

Pipeline new from Royal Philips, Janssen, Mylan, and Curis

June 11, 2018

Company Drug/Device Medical Condition Status
Peloton Therapeutics, Inc. PT2977 (oral HIF-2α inhibitor) Treatment of von Hippel-Linau (VHL) disease-associated kidney cancer Phase II trial initiated enrolling 50 subjects in the U.S.
Viking Therapeutics, Inc. VK2809 Primary hypercholesterolemia and non-alcoholic fatty liver desease (NAFLD) Phase II trial initiated
Tricida, Inc. TRCA-301 chronic kidney disease patients with metabolic acidosis Phase III trial initiated enrolling 217 subjects in the U.S. and Europe
Janssen (part of Johnson & Johnson) esketamine nasal spray adults with treatment-resistant depression Phase III trial initiated
Camber Spine Technologies ENZA (Titanium Anterior Lumbar Interbody Fusion (ALIF) system autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 510(k) clearance granted by the FDA
Royal Philips Ingenia Elition 3.0T MR solution increased diagnostic performance 510(k) clearance granted by the FDA
Partner Therapeutics, Inc. Leukine adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrom of Acute Radiation Syndrome) Approval granted by the FDA
Mylan Fulphila (pegfilgrastim-jmbd) febrile neutropenia Approval granted by the FDA
Eli Lilly and Incyte Corporation OLUMIANT (baricitnib) adults with moderately-to-severely active Rheumatoid Arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies Approval granted by the FDA
Micronics, Inc. PanNAT STEC Test Shiga toxin-producing E. Coli (STEC) Clearance granted by the FDA
Chugai Pharmaceutical Co., Ltd. HEMLIBRA (U.S. generic name: emicizumab-kxwh) adults and children with hemophilia A without factor VIII inhibitors Priority Review Designation granted by the FDA
Pfizer Talazoparib germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC) Priority Review Designation granted by the FDA
Pfizer Xalkori (crizotinib) relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive Breakthrough Therapy Designation granted by the FDA
AutoGenomics, Inc. INFINITI Neutral Response Panel opioid dependency Breakthrough Device Designation granted by the FDA
Curis, Inc. fimepinostat (CUDC-907) relapsed or fractory (R/R) diffuse large B-cell lymphoma (DLBCL) Fast Track Designation granted by the FDA
Alnylam Pharmaceuticals, Inc. ALN-TTRsc02 Transthyretin-mediated amyloidosis Orphan Drug Designation granted by the FDA

Pipeline new from Atox, Dova, Sage, Zeto and Pfizer

June 4, 2018

Company Drug/Device Medical Condition Status
NeoImmune Tech, Inc. HyLeukin-7 brain cancer Phase I trial initiated enrolling up to 75 subjects
Atox Bio Reltecimod Abdominal sepsis and Stage 2/3 Acute Kidney Injury (AKI) Phase II trial initiated enrolling 120 subjects at approximately 50 level 1 trauma centers in the U.S.
Atox Bio Reltecimod Necrotizing Soft Tissue Infections (NSTI) Phase III trial initiated enrolling 290 subjects at approximately 70 level 1 trauma sites in the U.S.
Synedgen Catasyn Advanced Technology Wound Hydrogel wound care 510(k) clearance granted by the FDA
Novartis Promacta (eltrombopag) Severe aplastic anemia (SAA) sNDA approval granted by the FDA
Nektar Therapeutics NKTR-181 chronic lower back pain NDA approval granted by the FDA
Sage Therapeutics brexanolone (SAGE-547) postpartum depression (PPD) NDA approval granted by the FDA
MicroVention, Inc. Low profile Visualized Intraluminal Support (LVIS) and LVIS Jr. neuro stent devices wide-necked saccular intracranial aneurysms PMA granted by the FDA
Dova Pharmaceuticals Doptelet (avatrombopag) thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure Approval granted by the FDA
TherapeuticsMD Imvexxy (TX-004HR) moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), symptom of vulvar and vaginal atrophy (VVA) Approval granted by the FDA
BioMarin Pharmaceutical Palynziq (pegvaliase-pqpz) Henylketonuria (PKU) Approval granted by the FDA
Zeto, Inc. zEEG dry electrode electroencephalography (EEG) headset Approval granted by the FDA
Astellas Pharma Inc. gilteritinib Relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation Priority Review granted by the FDA
Pfizer Xalkori (crizotinib) Metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy Breakthrough Therapy Designation granted by the FDA
Pfizer tafamidis Transthyretin cardiomyopathy Breakthrough Therapy Designation granted by the FDA
Yamo Pharmaceuticals, LLC L1-79 autism spectrum disorder (ASD) Fast Track Designation granted by the FDA
Genea Biocells GBC0905 Facioscapulohumeral muscular dystrophy (FSHD) Orphan Drug Designation granted by the FDA

Pipeline new from Pfizer, Amgen, AstraZeneca, Abbott and Janssen

May 29, 2018

Company Drug/Device Medical Condition Status
Pfizer Inc. investigational RSV vaccine respiratory syncytial virus (RSV) Phase I/II trial initiated enrolling healthy adult volunteers in two age groups of 18-49 and 50-85
Acceleron Pharma Inc. sotatercept pulmonary arterial hypertension (PAH) Phase II trial initiated enrolling 90 subjects
Nabriva Therapeutics lefamulin moderate community-acquired bacterial pneumonia (CABP) Phase III trial topline results reported
Providence Medical Technology, Inc. DTRAX Spinal System posterior cervical fusion in patients with cervical degenerative disc disease 510(k) clearance granted by the FDA
CERENOVUS, part of the Johnson & Johnson Medical Devices Companies EMBOTRAP II Revascularization Device next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke 510(k) clearance granted by the FDA
Lannett Company, Inc. Dronabinol Capsules HIV aNDA approval granted by the FDA
AcelRx Pharmaceuticals, Inc. DSUVIA moderate-to-severe acute pain for adult patients in medically supervised settings NDA approval granted by the FDA
Amgen and Novartis Aimovig (erenumab-aooe) preventative treatment of migraine in adults Approval granted by the FDA
Nestlé Skin Health hyaluronic acid (HA) dermal filler Restylane Lyft correction of age-related volume loss in the back of the hands for patients over the age of 21 Approval granted by the FDA
AstraZeneca Lokelma (sodium zirconium cyclosilicate) treatment of adults with hyperkalemia Approval granted by the FDA
Sun Pharmaceutical Industries Ltd. and Churchill Pharmaceuticals, LLC YONSA (abiraterone acetate) in combination with methylprednisolone metastatic castration-resistant prostate cancer (mCRPC) Approval granted by the FDA
Abbott XIENCE Sierra coronary artery diseasen Approval granted by the FDA
Janssen JULUCA (dolutegravir/rilpivirine) two-drug regimen, once-daily, single-pill for the treatment of human immunodeficiency virus type 1 (HIV-1) infection Approval granted by the EMA
WAT Medical EmeTerm nausea-induced vomiting Clearance granted by the FDA
UTILITY therapeutics Ltd mecillinam (injectable) and pivmecillinam (oral prodrug) complicated urinary tract infections (cUTI) QIDP Designation granted by the FDA
Harmony Biosciences, LLC pitolisant cataplexy in patients with narcolepsy Breakthrough Therapy Designation granted by the FDA
bluebird bio, Inc. Lenti-D cerebral adrenoleukodystrophy (CALD) Breakthrough Therapy Designation granted by the FDA
Harmony Biosciences, LLC pitolisant excessive daytime sleepiness in patients with narcolepsy Fast Track Designation granted by the FDA
Berg, LLC BPM 31510 (ubidecarenone) Epidermolysis Bullosa (EB) Orphan Drug Designation granted by the FDA

Pipeline new from Genentech, UCB, Pfizer, and Faxitron

May 21, 2018

Company Drug/Device Medical Condition Status
Entasis Therapeutics ETX0282 and ETX0282CPDP (combination of ETX0282 with cefpodoxime) Oral therapy for infections caused by multidrug-resistant (MDR) Gram-negative pathogens, including MDR and carbapenem-resistant Enterobacteriaceae (CRE) Phase I trial initiated enrolling healthy subjects from Australia
BioMarin Pharmaceutical Inc. Valoctocogene roxaparvovec Hemophilia A patients with pre-existing AAV5 antibodies Phase I/II trial initiated
Alkahest, Inc. ALK4290 and ALK4290-201 newly-diagnosed wet age-related macular degeneration and refractory wet age-related macular degeneration, respectively Phase II trials initiated
Regeneron Pharmaceuticals, Inc.and Sanofi DUPIXENT (dupilumab) moderate-to-severe atopic dermatitis in adolescents ages 12-17 Phase III trial initiated enrolling 251 subjects
MC10, Inc. BioStamp nPoint system data collection platform 510(k) clearance granted by the FDA
Caliber Imaging & Diagnostics Inc. VIVASCOPE System Reflectance confocal microscopy (RCM) devise 510(k) clearance granted by the FDA
CurveBeam LineUP Multi-extremity weight bearing CT system orthopedic extremity imaging 510(k) clearance granted by the FDA
Faxitron VisionCT fully enhances the clinician’s ability for detailed margin assessment by automatically taking images around the entire specimen and reconstructing a navigable 3D render in real time 510(k) clearance granted by the FDA
Turnstone Biologics MG1-HPV Human papillomavirus (HPV)-positive solid tumors IND clearance granted by the FDA
Amneal Pharmaceuticals, Inc. Generic Welchol (colesevelam HCI) 625 mg tablets Cholesterol aNDA approval granted by the FDA
US WorldMeds Lucemyra (lofexidine hydrochloride) mitigation of opioid withdrawl symptoms in adult Approval granted by the FDA
Pfizer Retacrit (epoetin alfaepbx) biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy or the use of zidovudine in patients with HIV infection Approval granted by the FDA
Genentech Actemra Active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age or older Approval granted by the FDA
UCB BRIVIACT (Brivaracetam) monotherapy or adjuctive therapy in patients four years of age and older with partial-onset seizures Approval granted by the FDA
BMG Pharma GelX oral mucositis Approval granted by the EMA
Castle Creek Pharmaceuticals diacerein 1% ointment (CCP-020) Epidermolysis bullosa (EB) Pediatric Disease Designation granted by the FDA
Immunicom, Inc. Immunopheresis therapy cancer tumors Breakthrough Device Designation granted by the FDA

Pipeline new from Bonti, Amneal, Janssen, PaxVax and Genentech

May 14, 2018

Company Drug/Device Medical Condition Status
Nektar Therapeutics NKTR-358 systemic lupus erythematosus (SLE) Phase Ib trial initiated evaluating 50 subjects
Bonti, Inc. EB-001T elective abdominoplasty surgery Phase II trial initiated
Amneal IPX203 advanced Parkinson’s disease Phase III trial initiated to enroll 500 subjects
Prisyna, the oral care division of Synedgen Moisyn product line xerostomia 510(k) clearance granted by the FDA
C4 Imaging LLC HDR MRI Marker use prior to high dose rate (HDR) brachytherapy to accurately locate the position of the applicators that guide the placement of radioactive sources for the treatment of multiple cancers 510(k) clearance granted by the FDA
Palladio Biosciences. Inc. lixivaptan capsules autosomal dominant polycystic kidney disease (ADPKD) IND clearance granted by the FDA
Portola Pharmaceuticals Andexxa antidote for blood thinners rivaroxaban and apixaban Approval granted by the FDA
Janssen Pharmaceutical Companiesof Johnson & Johnson DARZALEX (daratumumab) in combination with VELCADE (bortezomib), a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone – VMP newly-diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) Approval granted by the FDA
PaxVax, Inc. Chikungunya vaccine prevention of the chikungunya virus Fast Track Designation granted by the FDA
Debiopharm International SA Debio 1347 (FGFR 1-3 Inhibitor) unresectable or metastatic tumors with a specific FGFR gene alteration Fast Track Designation granted by the FDA
Genentech Tecentriq triple combination with Avastain (bevacizumab), paclitaxel and carboplatin (chemotherapy) first-line treatement of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) Priority Review granted by the FDA