Tag Archives: ema

October, 2018

8 October
FDA Accepts Novartis’ NDA for Investigational Siponimod for the Treatment of Secondary Progressive Multiple Sclerosis

Basel, October 08, 2018 – Novartis today announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company’s New Drug Application (NDA) and Marketing Authorization Application (MAA) respectively, for investigational oral, once-daily siponimod (BAF312) for the treatment of secondary progressive multiple sclerosis (SPMS) in …
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7 June
Pfizer’s Talazoparib Granted FDA Priority Review for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) …
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18 January
FDA and EMA Accept Boehringer Ingelheim’s Biosimilar Candidate to Humira for Review

Ingelheim, Germany, January 18, 2017 – Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira®*, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S Food and Drug Administration (FDA). “We believe that if approved, BI 695501 can provide a valuable …
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7 September
Merck Announces FDA’s Priority Review for sBLA for Keytruda

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small …
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4 April
Samsung Bioepis’ Infliximab Biosimilar Recommended for Approval in the European Union

INCHEON, Korea – April 1, 2016 – Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Flixabi® – a biosimilar version of Remicade® (infliximab), also known as SB2 – for the treatment of …
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4 April
GSK’s New Gene Therapy Receives Positive CHMP Opinion in Europe for Treatment of ADA-SCID

GlaxoSmithKline (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has issued a positive opinion recommending marketing authorisation for Strimvelis to treat patients with a very rare disease called ADA-SCID …
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2 March
Baxalta Submits MAA to the EMA for its Hemophilia A Treatment

BANNOCKBURN, Ill.–(BUSINESS WIRE)– Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval of ADYNOVI, an extended circulating half-life recombinant Factor …
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26 February
AbbVie Announces Positive CHMP Opinion for Viekirax without Ribavirin in HCV

NORTH CHICAGO, Ill., Feb. 26, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without …
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25 February
AstraZeneca and Acerta Pharma’s Acalabrutinib Recommended for EU Orphan Status for 3 Indications

AstraZeneca and Acerta Pharma BV, a company in which AstraZeneca has a majority equity investment, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product. The three positive opinions are for the …
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13 January
FDA Grants Priority Review for AbbVie’s Leukemia Candidate

NORTH CHICAGO, Ill., Jan. 12, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) accepted AbbVie’s New Drug Application (NDA) granting priority review for venetoclax for the treatment of chronic lymphocytic leukemia (CLL) in adults who have received at …
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