USFDA

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that its state-of-the-art recombinant biologic manufacturing facility in Singapore received U.S. Food and Drug Administration (FDA) approval to produce ADVATE [Antihemophilic Factor (Recombinant)] bulk drug substance (BDS). The site received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE.

U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma. Darzalex is marketed by Janssen Biotech of Horsham, Pennsylvania.

AstraZeneca announced that the US Food and Drug Administration (FDA) has approved TAGRISSO (AZD9291) 80mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

The U.S. Food and Drug Administration approved Baxalta US Inc, Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding.

Immune Pharmaceuticals Inc. announced that the US Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for its first in class, lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP). This FDA acceptance enables the company to expand recruitment for its clinical trials.

Drugmaker Gilead Sciences Inc said U.S. Food and Drug Administration had approved the expanded use of its blockbuster hepatitis C drug, Harvoni. The drug can now be used to treat patients with subtypes of chronic hepatitis C virus (HCV) and patients who are co-infected with Human Immunodeficiency Virus (HIV), Gilead said in a statement. Gilead's Harvoni was first approved by the FDA in October 2014.

The U.S. Food and Drug Administration approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).

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The US Food and Drug Administration (FDA) has granted rare paediatric disease designation to ArmaGen Inc's AGT-181, a potential treatment for patients with Hurler syndrome, a disease that is also known as mucopolysaccharidosis type I (MPS I).

Espero Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for GoNitro for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

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Merck & Co's drug to reverse the effects of muscle relaxants used in surgery is safe and effective enough to warrant approval, an independent panel to the U.S. Food and Drug Administration said. The drug, which goes by the chemical name of sugammadex, has repeatedly been rejected by the FDA due to concerns about potentially dangerous allergic reactions, even though it is approved in more than 75 countries.