US FDA

AstraZeneca and Daiichi Sankyo’s BLA for Datopotamab Deruxtecan Accepted by FDA for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo's Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been acknowledged by the US…

4 weeks ago

AstraZeneca’s Truqap Receives US FDA Approval for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca's Truqap (capivasertib) in combination with Faslodex (fulvestrant) has gained approval from the US Food and Drug Administration…

5 months ago

SGS can now offer FSMA certification for VQIP and FSVP to foreign food importers into the U.S.

(PRESS RELEASE) GENEVA, 13-Feb-2019 — /EuropaWire/ — SGS can now certify foreign food suppliers under the US Food and Drug Administration (FDA)'s…

5 years ago

Novartis division Sandoz receives US FDA complete response letter regarding the Biologics Licensing Application for its proposed biosimilar rituximab

Holzkirchen, Germany, 04-May-2018 — /EuropaWire/ — Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has…

6 years ago

Diabetes: US FDA approval for Medtronic’s Guardian(TM) Connect continuous glucose monitoring (CGM) system

 'Smart' CGM System Provides Predictive Alerts for Dangerous Sensor Glucose Levels; Exclusive Access to Sugar.IQ Assistant with Watson Offers More Proactive Diabetes…

6 years ago

Shire plc files its first submission to the US FDA for its new plasma manufacturing facility in Covington, GA

DUBLIN, 02-Jan-2018 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced that…

6 years ago

GSK: NDA submission to US FDA for single-dose tafenoquine for the radical cure of Plasmodium vivax malaria

Regulatory milestone affirms GSK's strong commitment and scientific capabilities to fighting infectious diseases  LONDON/GENEVA, 29-Nov-2017 — /EuropaWire/ — GSK and Medicines…

6 years ago

US FDA gives Actamax go signal to conduct trial on Actamax Adhesion Barrier

Parsippany NJ, US, 25-Sep-2017 — /EuropaWire/ — Actamax Surgical Materials LLC, a wholly owned subsidiary of DSM, focused on design of…

7 years ago

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)…

7 years ago

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…

7 years ago

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…

8 years ago

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…

8 years ago

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…

9 years ago

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…

9 years ago

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…

9 years ago

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…

10 years ago

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]…

10 years ago

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…

11 years ago

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…

11 years ago

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…

11 years ago