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Two FDA advisory committees recommended the FDA approve KemPharm’s opioid pill Apadaz, even though they rejected an abuse-deterrent label for the candidate. Read More
FDA Commissioner Robert Califf made a forceful call for “adequate” funding from Congress to implement pending biomedical innovation legislation. Read More
Sanofi is not bowing out of its efforts to buy Medivation, warning the company’s board that if it continues to brush off its overtures, it will pursue a hostile bid. Read More
Two FDA advisory committees voted unanimously to recommend modifications to the REMS for extended-release and long-acting opioids, although the recommendation did not get into specific courses of action. Read More
A newly released Form 483 faults Indian drugmaker Glenmark Pharmaceuticals for neglecting multiple controls in its procedures at its Pithampur facility. Read More