IRVINE, Calif.–(BUSINESS WIRE)–Mar 10, 2010 – Allergan, Inc.
today announced that the United States Food and Drug
Administration (FDA) has approved Botox (onabotulinumtoxinA) for
the treatment of increased muscle stiffness in the elbow, wrist…
BRISBANE, Calif., March 5 /PRNewswire-FirstCall/ — InterMune,
Inc. announced today that the U.S. Food
and Drug Administration (FDA) has posted briefing documents for the
March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting
to…
KING OF PRUSSIA, Pa.–(BUSINESS WIRE)–Mar 4, 2010 – CSL Behring announced today that the U.S. Food and Drug
Administration (FDA) has granted marketing approval for
Hizentra, Immune Globulin Subcutaneous (Human), 20%
Liquid, for treating patients…
Sophia Antipolis, France, March 8, 2010. -NicOx S.A. today announces that on Wednesday, May 12,
2010, the US Food and Drug Administration (FDA) plans to hold a
meeting of the Arthritis Drugs Advisory Committee and the Drug
Safety and Risk…
SEATTLE, March 1 /PRNewswire-FirstCall/ — Cell Therapeutics,
Inc. announced today that the U.S.
Food and Drug Administration’s (“FDA”) Oncologic Drugs Advisory
Committee (“ODAC”) will review CTI’s New Drug Application (“NDA”)
for pixantrone for…
MOUNTAIN VIEW, Calif.,
March 1 /PRNewswire-FirstCall/ –
VIVUS, Inc. today announced that the U.S. Food and
Drug Administration (FDA) has accepted for filing the company’s new
drug application (NDA) for its investigational drug, Qnexa,
for the…
MELBOURNE, Australia & MENLO PARK, Calif.– Mar 2, 2010 – ChemGenex Pharmaceuticals Limited announced today that the U.S.
Food and Drug Administration (FDA) has rescheduled the previously
postponed Oncologic Drugs Advisory Committee (ODAC) meeting…
SAN DIEGO, March 1 /PRNewswire-FirstCall/ —
ADVENTRX Pharmaceuticals, Inc. announced today that it received a refuse to file letter from
the U.S. Food and Drug Administration (FDA) regarding its New Drug
Application (NDA) for ANX-530…
PRINCETON, N.J.–(BUSINESS WIRE)–Mar 2, 2010 – Bristol-Myers Squibb Company today announced that
the U.S. Food and Drug Administration’s (FDA) Cardiovascular and
Renal Drugs Advisory Committee has voted 13 to 5 to recommend
approval of…
HAYWARD, Calif.–(BUSINESS WIRE)–Mar 2, 2010 – Impax
Laboratories, Inc. today announced that the U.S.
Food and Drug Administration (FDA) has granted final approval of
the Company’s Abbreviated New Drug Application (ANDA) for the
generic version…
NEW HAVEN, Conn., Feb. 26 /PRNewswire-FirstCall/ — Vion
Pharmaceuticals, Inc. announced
today that it had received a response from the U.S. Food and Drug
Administration (FDA) on a Special Protocol Assessment (“SPA”) for
its oncology therapeutic…
ST. LOUIS–(BUSINESS WIRE)–Mar 2, 2010 – Covidien today announced that the U.S. Food and Drug Administration (FDA)
has approved the New Drug Application 21-217 for Exalgo
(hydromorphone HCl) Extended-Release Tablets, (CII).
The indication for…
MELVILLE, N.Y., February 25, 2010 /PRNewswire/ — E. Fougera
& Co., a leading specialty pharmaceutical manufacturer, today
announced it has received first generic approval from the FDA for
Imiquimod Cream 5% (Rx). Fougera’s Imiquimod Cream 5% is…
SAN DIEGO, Feb. 26, 2010 /PRNewswire-FirstCall/ — Arena
Pharmaceuticals, Inc. announced today that the US Food
and Drug Administration (FDA) has assigned a Prescription Drug User
Fee Act (PDUFA) date of October 22, 2010, for the review of…
SAN DIEGO, Feb. 24, 2010 /PRNewswire-FirstCall/ — Arena
Pharmaceuticals, Inc. announced today that its New Drug
Application (NDA) for lorcaserin, Arena’s internally discovered and
developed drug candidate for weight management, including…
