USFDA

Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Almotriptan Tablets USP, 6.25 mg and 12.5 mg, the generic version of Janssen Pharmaceutical's AXERT®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used for the acute treatment of migraine attacks in adult patients with a history of migraine with or without aura. In adolescents age 12 to 17 years, it is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).

Collegium Pharmaceutical, Inc.  announced that the United States Food and Drug Administration (FDA) has granted tentative approval to the Company's New Drug Application (NDA) for Xtampza™ ER (oxycodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

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Protalix BioTherapeutics, Inc.  announced that it recently held an End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) to discuss the Company's proposed BLA plan for PRX-102 for the treatment of Fabry disease. Official FDA meeting minutes indicate the FDA's acceptance of the Company's path forward for a phase III clinical trial to support a full BLA approval.

Mallinckrodt plc, a leading specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared INOmax DSIR® Plus MRI device for delivery of INOMAX® (nitric oxide) for inhalation during MRI procedures.

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.