Tag Archives: US FDA

GSK: US FDA VRBPAC’s vote brings us one step closer to approval of Shingrix

LONDON, 14-Sep-2017 — /EuropaWire/ — GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the efficacy and safety of Shingrix … Read the full press release

Acerta Pharma: US FDA accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib inhibitor

CAMBRIDGE, 07-Aug-2017 — /EuropaWire/ — AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib, … Read the full press release

US FDA grants accelerated approval to Roche’s Alecensa® for the treatment of people with specific type of lung cancer

BASEL, 14-12-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) granted accelerated approval to Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer … Read the full press release

Sandoz continues to advance its biosimilars program: US FDA acceptance for its proposed biosimilar pegfilgrastim

Sandoz continues to advance its biosimilars program: Regulatory submission for Sandoz’ proposed biosimilar pegfilgrastim accepted by the FDA Sandoz demonstrates commitment to oncology by seeking approval for its proposed biosimilar pegfilgrastim. Sandoz believes that the totality of evidence in its … Read the full press release

Novartis: US FDA approved Promacta for the treatment of children six years and older with chronic immune thrombocytopenia (ITP)

Promacta® (eltrombopag) significantly increased and sustained platelet counts in two studies, including the largest Phase III clinical trial in this patient population Characterized by a low platelet count[1], ITP can affect up to 5 in 100,000 children each year[2] and … Read the full press release

Sanofi and its subsidiary Genzyme announced that US FDA granted Breakthrough Therapy designation to olipudase alfa

Investigational Enzyme Replacement Therapy to Treat Non-Neurological Manifestations which characterize Niemann-Pick Type B PARIS, 5-6-2015 — /EuropaWire/ — Sanofi and its subsidiary Genzyme announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olipudase alfa. … Read the full press release

AstraZeneca announced that the US FDA accepted for filing the New Drug Application for IRESSA® (gefitinib)

LONDON, 2-12-2014 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for IRESSA® (gefitinib) as a targeted monotherapy for the first line treatment of patients with … Read the full press release

AstraZeneca’s novel antibiotic candidate AZD0914 designated as Qualified Infectious Disease Product and awarded Fast Track status by US FDA

London, UK, 03-6-2014 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has designated its novel investigational drug AZD0914 as a Qualified Infectious Disease Product (QIDP) and awarded its development programme Fast Track status for the treatment … Read the full press release

AstraZeneca and Bristol-Myers Squibb Company announce US FDA approved FARXIGA™ (dapagliflozin) for type 2 diabetes adult patients treatment

London, UK, 15-1-2014 — /EuropaWire/ — AstraZeneca and Bristol-Myers Squibb Company announced the US Food and Drug Administration (FDA) approved FARXIGA™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycaemic control in adults with … Read the full press release

GlaxoSmithKline submitted NDA to US FDA for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA™ dry powder inhaler

London, UK, 23-10-2013 — /EuropaWire/ — GlaxoSmithKline plc (LSE:GSK) today announced the submission of a New Drug Application (NDA) in the US for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA™ dry powder inhaler. The NDA … Read the full press release

EMA and US FDA published joint first conclusions of parallel assessment of quality-by-design applications (QbD)

29-8-2013 — /EuropaWire/ — The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications. Quality-by-design is a science- and … Read the full press release

US FDA granted breakthrough therapy designation to Novartis’s BYM338 for sporadic inclusion body myositis

Designation highlights potential of BYM338 to address an unmet medical need in a serious disease If approved, BYM338 has the potential to be the first treatment for sIBM patients BYM338 is the third Novartis investigational treatment this year to receive … Read the full press release