Drugs in the Pipeline
Portola has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for approval to market the investigational treatment betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE).
Solid Biosciences and Solid GT announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for SGT-001 for the treatment of patients with Duchenne muscular dystrophy (DMD).
Melinta Therapeutics announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for approval of intravenous (IV) and oral Baxdela (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for Priority Review.
Positive topline results have been announced for ALKS 5461, a once-daily, oral investigational drug for the adjunctive treatment of major depressive disorder.
Gilead has announced positive results from four Phase 3 clinical studies of once-daily, fixed-dose combination of sofosbuvir (SOF), velpatasvir (VEL), and voxilaprevir (VOX; GS-9857), for the treatment of genotype 1-6 chronic hepatitis C infection.
Theravance Biopharma and Mylan have announced positive results from two replicate Phase 3 studies of revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD).
Merck announced that the Phase 3 clinical study of letermovir for the prevention of clinically significant cytomegalovirus (CMV) infection in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT) patients met its primary endpoint.
AbbVie has announced positive results from two replicate Phase 3 clinical trials of Elagolix in premenopausal women with endometriosis.
At the American College of Gastroenterology (ACG) annual scientific meeting, Synergy presented new long-term safety data of plecanatide for the treatment of chronic idiopathic constipation (CIC).
The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam; Allergen), for the addition of new Phase 3 data to the label.
MediciNova announced that the Food and Drug Administration (FDA) has granted orphan drug designation to MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS).
Viamet has announced that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designation to VT-1161, a novel treatment for recurrant vulvovaginal candidiasis (RVVC).
The Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA), and granted Priority Review, for Lucentis (ranibizumab injection; Genentech), to expand its indication for the treatment of myopic choroidal neovascularization (mCNV).
Smokers may also benefit, results of a clinical trial suggest
Renal and Urology News Articles
NEPHROLOGY & UROLOGY NEWS
- Acute Kidney Injury (AKI)
- Chronic Kidney Disease (CKD)
- Contrast Nephropathy
- Cardiovascular Disease (CVD)
- Diabetic Nephropathy
- End-stage Renal Disease (ESRD)
- Lupus Nephritis
- Peritoneal Dialysis
- Secondary Hyperparathyroidism (SHPT)