In anticipation of the U.S. approval of Bydureon, San Diego's Amylin Pharmaceuticals ($AMLN) was already amping up production of the diabetes drug at its West Chester Township, OH, plant where...
2011 was a big year for drugmakers seeking to get their innovative products approved, as the FDA blessed 30 new drugs, a 7-year high. Among the lucky ones were Johnson & Johnson ($JNJ) and
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
The FDA slammed Alexza Pharmaceuticals ($ALXA) with another setback this week in its drive to bring the antipsychotic drug Adasuve to market. Regulators are extending by three months their review of
Pfizer ($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....
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
An FDA panel of experts recommended approval for Alexza Pharmaceuticals' ($ALXA) inhaled, fast-acting antipsychotic drug Adasuve, as long as the company limits the dose to once a day and follows
That loud ticking noise must have been stressful for Ranbaxy executives yesterday. For most of the day, it appeared to the outside world the massive generic- Lipitor market opportunity was passing
Pharmacy services provider PharMerica Corp. is questioning claims made recently by KV Pharmaceutical ($KV.A) that the latter's FDA-approved premature-birth prevention drug Makena provides greater
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,