Tag Archives: Application

VIEW ALL

Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Feb 27, 2013 – SunovionPharmaceuticals Inc. (Sunovion) today announced that the U.S. Foodand Drug Administration (FDA) has accepted for review the…
Continue reading

Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA

PARIS, Feb. 19, 2013 /PRNewswire/ — Sanofi announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a New…
Continue reading

GSK and Theravance Announce FDA Acceptance of New Drug Application Submission in the

LONDON and SOUTH SAN FRANCISCO, CA — (Marketwire) — 02/19/13– GlaxoSmithKline plc and Theravance, Inc. today announced that the New Drug Application (NDA)…
Continue reading

Genzyme’s Lemtrada (alemtuzumab) Application for MS Accepted for Review by the FDA

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jan 28, 2013 – Genzyme, a Sanofi Company,announced that the U.S. Food and Drug Administration (FDA) hasaccepted for review the company’s…
Continue reading

Merck Announces FDA Acceptance of New Drug Application for Investigational Ophthalmic

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Mar 9, 2011 – Merck, known as MSD outside the United States and Canada,announced today that the New Drug Application…
Continue reading

FDA Accepts New Drug Application for Investigational Compound Dapagliflozin for the T

PRINCETON, N.J. & LONDON–(BUSINESS WIRE)–Mar 8, 2011 – Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug oeffentliche Hand…
Continue reading

Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory

BOTHELL, Wash.–(BUSINESS WIRE)–Feb 28, 2011 – Seattle Genetics, Inc. announced today that it has submitted a Biologics License Application (BLA) to the U.S.…
Continue reading

Merck Receives Complete Response Letter From FDA on Cladribine Tablets New Drug Appli

DARMSTADT, Germany, March 2, 2011 ? Merck Kommanditgesellschaft auf Aktien announced today that it received a complete response letter from the FDA on…
Continue reading

FDA Accepts Lundbeck Inc. Submission of New Drug Application for Clobazam

DEERFIELD, Ill.–(BUSINESS WIRE)–Mar 4, 2011 – Lundbeck Inc. today announced the U.S. Food and Drug Administration (FDA) has accepted for review a New…
Continue reading

FDA Denies Taliglucerase Alfa New Drug Application

February 25, 2011 – On Friday morning, Protalix BioTherapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has issued a Complete…
Continue reading

Federal Way Says No To Medical Marijuana Dispensaries

City Denies Business LicensesFederal Way has declared that two medical marijuana dispensaries are illegal businesses.Conscious Care Cooperative and GAME Collective both received cease-and-desist…
Continue reading

US FDA Assigns New PDUFA Date for Brilinta (ticagrelor tablets)

(link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für…
Continue reading

Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011

(link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für…
Continue reading

Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of

(link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für registrierte Benutzer sichtbar, login oder registriere dich) (link nur für…
Continue reading

VIVUS Provides Regulatory Update on Qnexa NDA

MOUNTAIN VIEW, Calif., Jan. 21, 2011 /PRNewswire/ — VIVUS, Inc. today announced that it held an End-of-Review meeting with the Food and Drug…
Continue reading
 

Facebook

    Subscribe Contact Me Popular Social
 
Thank you for subscription!
 
Thank you! Your message has been submitted to us.