March 20, 2018
Hikma launches Ritonavir Tablets USP
Hikma Pharmaceuticals’s wholly owned US subsidiary West-Ward Pharmaceuticals, has launched Ritonavir Tablets USP, 100 mg, the first AB-rated generic to…
Pharmaceuticals, Biotechnology and Life Sciences
Tag: FDA
February 28, 2018
Novo Nordisk files for regulatory approval in the US and the EU for treatment of haemophilia A
Novo Nordisk has submitted a Biologics License Applications (BLA) to the US Food and Drug Administration (FDA) and a Marketing…
February 28, 2018
FDA rejects Celgene’s NDA for multiple sclerosis treatment
Celgene Corporation (NASDAQ:CELG) has received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding its New Drug…
February 16, 2018
Apricus stocks fall down as its erectile dysfunction cream doesn’t satisfy the FDA
Apricus Biosciences, a biopharmaceutical company urology and rheumatology focused drug-maker, will have to fire another shot at getting its topical cream…
February 15, 2018
FDA approves Janssen’s prostate cancer drug
The U.S. Food and Drug Administration has approved Janssen Pharmaceutical ‘sErleada (apalutamide) for the treatment of patients with prostate cancer that has…
January 31, 2018
Alkermes waits FDA’s green light for its investigational depressive disorder treatment
Alkermes will attempt to get new approval from the USFDA for its investigational drug for treating major depressive disorder (MDD).
January 29, 2018
Faron’s Traumakine on Fast Track, as the US FDA says it’s good to go
Faron Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for Traumakine, which also has…
January 25, 2018
Endo pauses lawsuit against FDA until end of March
Endo International Wednesday said stay of the litigation against FDA made in October 2017 by its subsidiaries, Par Sterile Products, LLC and…
January 23, 2018
U.S. FDA OK’s Baxter’s ready-to-use cardiovascular medication Bivalirudin
Baxter International has announced the U.S. Food and Drug Administration (FDA) approval of Bivalirudin in 0.9 percent Sodium Chloride Injection…
January 17, 2018
FDA and EMA see Novartis’s Kymriah as an option for patients with relapsed or refractory B-cell ALL and DLBCL
The FDA has set Novartis’s Kymriah suspension injection for patients who have relapsed or refractory diffuse large B-cell lymphona (DLBCL)…