Spark Therapeutics and Novartis have secured the approval from the European Commission (EC) for their one-time gene therapy Luxturna (voretigene neparvovec) to treat patients with a rare inherited form of vision loss that could lead to blindness.
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Daurismo (glasdegib) to treat adult patients with newly-diagnosed acute myeloid leukemia (AML) for whom intensive chemotherapy is not an option.
Takeda Pharmaceutical has secured clearance from the European Commission (EC) for its proposed $62bn acquisition of Shire.
Dr. Reddy’s Laboratories said that the US Court of Appeals for the Federal Circuit issued a decision in its favor by concluding that Indivior had not shown that it is likely to succeed on the merits of its infringement case on US Patent No. 9,931,305.
Swedish Orphan Biovitrum (Sobi) and Novimmune have secured approval from the US Food and Drug Administration (FDA) for their monoclonal antibody Gamifant (emapalumab-lzsg) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH).
The US Food and Drug Administration (FDA) has approved Aries Pharmaceuticals’ Aemcolo (rifamycin) 194mg delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for the treatment of adult patients with Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli.
GlaxoSmithKline (GSK) has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for an additional indication for Nucala (mepolizumab) as an add-on treatment for severe eosinophilic asthma in paediatric patients aged six to 11 years.
The US Food and Drug Administration (FDA) has expanded the label for Novartis’ Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy (IST).
Bristol-Myers Squibb (BMS) said that European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the approval of Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted two Type II variation applications to the European Medicines Agency (EMA) regarding approval for the expanded use of IMBRUVICA (ibrutinib).
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.