WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Aug 30, 2010 – Eisai Inc.
announced today that it has received notification from the U.S.
Food and Drug Administration (FDA) that the agency expects to
complete priority review of the eribulin mesylate New…
EAST HANOVER, N.J., Aug. 27 /PRNewswire/ — The US Food and Drug
Administration (FDA) approved Tekamlo (aliskiren and
amlodipine) tablets, a single-pill for the treatment of high blood
pressure combining the only approved direct renin…
EAST HANOVER, N.J., Aug. 27 /PRNewswire/ — The US Food and Drug
Administration (FDA) approved Tekamlo (aliskiren and
amlodipine) tablets, a single-pill for the treatment of high blood
pressure combining the only approved direct renin…
PALO ALTO, Calif., Aug. 20 /PRNewswire-FirstCall/ — Jazz
Pharmaceuticals, Inc. announced today that the Joint
Advisory Committee of the U.S. Food and Drug Administration (FDA),
including the Arthritis Advisory Committee and the Drug Safety…
TARRYTOWN, N.Y.–(BUSINESS WIRE)–Aug 23, 2010 – Regulatory
News:
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange:
EPCT) today announced that it received a refusal to file letter
from the U.S. Food and Drug Administration (FDA) on…
ROCKVILLE, Md.–(BUSINESS WIRE)–Aug 19, 2010 – Human Genome
Sciences, Inc. and GlaxoSmithKline PLC (GSK) today
announced that the U.S. Food and Drug Administration (FDA) has
granted a priority review designation to Benlysta (belimumab)
as a…
ROCKVILLE, Md.–(BUSINESS WIRE)–Aug 19, 2010 – Human Genome
Sciences, Inc. and GlaxoSmithKline PLC (GSK) today
announced that the U.S. Food and Drug Administration (FDA) has
granted a priority review designation to Benlysta (belimumab)
as a…
PRINCETON, N.J.–(BUSINESS WIRE)–Aug 18, 2010 – Bristol-Myers Squibb Company today announced that
the U.S. Food and Drug Administration (FDA) has accepted, for
filing and review, the Biologics License Application (BLA) for
ipilimumab for the…
ROCKVILLE, Md., Aug. 13, 2010–The U.S. Food and Drug
Administration today approved ella (ulipristal acetate)
tablets for emergency contraception. The prescription-only product
prevents pregnancy when taken orally within 120 hours (five…
RESEARCH TRIANGLE PARK, N.C. and ALISO VIEJO, Calif., Aug. 11
/PRNewswire-FirstCall/ — GlaxoSmithKline and Valeant
Pharmaceuticals International announced today that a
U.S. Food and Drug Administration (FDA) advisory committee voted
unanimously…
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Aug 10, 2010 -
Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration
(FDA) approved increasing the length of therapy with Valcyte
(valganciclovir…
SAN DIEGO and WOODCLIFF LAKE, N.J., Aug. 6, 2010
/PRNewswire-FirstCall/ — Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug
Administration (FDA) has notified the company of the confirmed
scheduling of an…
JERSEY CITY, N.J.–(BUSINESS WIRE)–Aug 4, 2010 – Lux
Biosciences, Inc. today announced that the U.S. Food and Drug
Administration’s Center of Drug Evaluation and Research has issued
a Complete Response letter regarding the New Drug Application…
BRIDGEWATER, N.J., Aug. 5 /PRNewswire/ — Sanofi-aventis U.S.
announced today that the U.S. Food and Drug Administration (FDA)
has approved a new one-vial formulation of its chemotherapeutic
agent Taxotere (docetaxel) Injection Concentrate. The…
BRIDGEWATER, N.J., Aug. 5 /PRNewswire/ — Sanofi-aventis U.S.
announced today that the U.S. Food and Drug Administration (FDA)
has approved a new one-vial formulation of its chemotherapeutic
agent Taxotere (docetaxel) Injection Concentrate. The…
