FDA approval

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Latest Headlines

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

UPDATED: FDA panel recommends approving Alexza's inhaled antipsychotic in split vote

An FDA panel of experts recommended approval for Alexza Pharmaceuticals' ($ALXA) inhaled, fast-acting antipsychotic drug Adasuve, as long as the company limits the dose to once a day and follows

Ranbaxy drama shows manufacturing impact on pharma business

That loud ticking noise must have been stressful for Ranbaxy executives yesterday. For most of the day, it appeared to the outside world the massive generic- Lipitor market opportunity was passing

Compounder questions KV's Makena purity claim

Pharmacy services provider PharMerica Corp. is questioning claims made recently by KV Pharmaceutical ($KV.A) that the latter's FDA-approved premature-birth prevention drug Makena provides greater

Report: Senate staffers hammering out accelerated drug approval pathway

BIO and Sen. Kay Hagan (D-NC) are working on draft legislation that would clear a shortcut through clinical trials straight through to the FDA for developers engaged in rare disease drug work,