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FDA approval

Latest Headlines

Latest Headlines

FDA panel backs GSK's Votrient for soft-tissue sarcoma

Good news came for GlaxoSmithKline ($GSK) Tuesday after the FDA's Oncologic Drugs Advisory Committee voted 11 to 2 in favor of approving Votrient to treat patients with advanced soft tissue sarcoma who have received prior chemotherapy. The FDA approved Votrient in 2009 to treat advanced renal cell carcinoma.

Discovery Labs shares rocket up on long-awaited FDA approval

For Discovery Laboratories, the fifth try proved the charm. FDA regulators have finally stamped an approval on Surfaxin as a guard against respiratory distress syndrome in infants after four rejections spread out over an 8-year regulatory odyssey.

AstraZeneca's FluMist Quadrivalent to hit U.S. market

The FDA has approved AstraZeneca's ($AZN) nasal FluMist Quadrivalent flu vaccine for use in people ages 2 to 49. Made at AstraZeneca's MedImmune unit, FluMist Quadrivalent contains two...

AstraZeneca's FluMist Quadrivalent to hit U.S. market

The FDA has approved AstraZeneca's ($AZN) nasal FluMist Quadrivalent flu vaccine for use in people ages 2 to 49. Made at AstraZeneca's MedImmune unit, FluMist Quadrivalent contains two...

Amylin's OH plant prepped for Bydureon's U.S. debut

In anticipation of the U.S. approval of Bydureon, San Diego's Amylin Pharmaceuticals ($AMLN) was already amping up production of the diabetes drug at its West Chester Township, OH, plant where...

FDA's new-drug approvals of 2011

2011 was a big year for drugmakers seeking to get their innovative products approved, as the FDA blessed 30 new drugs, a 7-year high. Among the lucky ones were Johnson & Johnson ($JNJ) and

FDA approvals of 2011

By Liz Jones Hollis and Jennifer Levin Welcome to our annual look back at FDA approvals. 2011 was a big year for drugmakers seeking to get their innovative products approved, as the FDA was busy. In

Alexza's Adasuve slapped with delayed FDA review

The FDA slammed Alexza Pharmaceuticals ($ALXA) with another setback this week in its drive to bring the antipsychotic drug Adasuve to market. Regulators are extending by three months their review of

FDA approves Pfizer's Prevnar 13 for adults over 50

Pfizer ($PFE) has won a much-anticipated FDA approval for Prevnar 13 for older adults to prevent pneumonia and other diseases caused by 13 Streptococcus pneumoniae serotypes contained in the vaccine....

Spike in approvals can't quell industry protests about the FDA

Throughout 2011 you could hear a growing chorus in the biopharma industry complain bitterly about the tougher regulatory challenges facing drug developers. Antibiotics got tougher. Diabetes got