Pharmaceuticals, Biotechnology and Life Sciences
Tetraphase Pharmaceuticals Inc Chief Executive Guy Macdonald said annual sales of the company’s lead experimental antibiotic for serious bacterial infections could climb as high as $700 million if approved.
U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) does not plan to hold an Advisory Committee meeting with Portola Pharmaceuticals for New Drug Application (NDA) for betrixaban, Portola said on Wednesday.
Amgen has been given green light in the USA for its Parsabiv, the cure for chronic kidney disease patients on hemodialysis to treat secondary hyperparathyroidism (HPT).
Kingsway Trading of Brooklyn, NY is recalling its 1.06 oz (30g) bottles of “Well Balance Xanthium & Siler Combo (Bi Yan Pian)” Batch No. 130401 & Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item, FDA said.
U.S. Food and Drug Administration (FDA) has granted a French based biopharmaceutical company Cellectis an Investigational New Drug (IND) approval to start first phase clinical trial with UCART123 in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Portola Pharmaceuticals has signed a $150 million royalty deal with HealthCare Royalty Partners (HCR).
GenSight Biologics, a biopharma company that discovers and develops innovative gene therapies for neurodegenerative retinal diseases and diseases of the central nervous system, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the Company’s product candidate GS030 for the treatment of retinitis pigmentosa.
Realm Therapeutics has submitted its first investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for PR022, as a novel treatment for atopic dermatitis (AD).
FDA found that certain teething tablets for children sometimes exceed the amount of belladonna – a toxic substance – and has asked the company that makes them to recall such medicine.
BD (Becton, Dickinson and Company) has launched its new BD Institute for Medication Management Excellence, developed to help advance the safe and efficient management of medication across the continuum of care.