Pharmaceuticals, Biotechnology and Life Sciences
Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to…
Merck KGaA and Pfizer have announced that the US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.
A federal judge in the U.S. District Court for the District of South Dakota yesterday granted the U.S. Food and…
Alkermes plcp has announced that the U.S. Food and Drug Administration (FDA) has approved Aristadatm (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
The U.S. Food and Drug Administration ordered on Monday the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.
Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
Novartis’s Alcon has received US Food and Drug Administration (FDA) approval for its AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System for patients undergoing cataract surgery.
Novartis company has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel (etanercept) – a tumor necrosis factor alpha (TNF-alpha) inhibitor.
The Food and Drug Administration (FDA) is advising consumers not to purchase or use NATUREAL, a product promoted and sold for weight loss.
Allergan plc has announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market Juvederm ultra XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21.