MYLAN INC: Announces FDA Approval of Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder)

Wixela™ Inhub™ is the first FDA-approved therapeutically equivalent generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder) for certain patients with asthma or chronic obstructive pulmonary disease (COPD) Read More »

SUNOVION PHARMACEUTICALS INC: Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)

Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat OFF episodes (the re-emergence or worsening of Parkinson’s symptoms otherwise controlled by medications) experienced by people living with Parkinson’s disease (PD). Read More »

DAIICHI SANKYO, INC.: FDA Grants Priority Review for Daiichi Sankyo's New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Read More »

SANOFI: FDA grants priority review for Dupixent® (dupilumab) as potential treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. Read More »

BRISTOL-MYERS SQUIBB: European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Read More »