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Controversy often arises around FDA’s drug approval decisions when the system fails to produce reliable evidence of risks and benefits, says FDA Commissioner Robert Califf, alluding to recent criticism of the agency for bypassing advisory committee recommendations. Read More
Paxlovid is authorized for treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kg. Read More
Novartis spin-off Alcon will pick up Aerie Pharmaceuticals, expanding Alcon’s eye care products focus into the prescription pharmaceuticals arena. Read More
Days after announcing a bankruptcy filing to restructure more than $8 billion in debt, Endo International has lost a long-contested patent lawsuit, piling more woes on the beleaguered company. Read More
The role of FDA advisory committees is “malleable” and the public would trust the FDA more if the agency aligned its decisions on drug approvals with the decisions by the expert panels. Read More
Morton Grove Pharmaceuticals (MGP), a division of Mumbai, India-based generics maker Wockhardt, is shutting down operations at its plant in a suburb of Chicago after receiving a court order from the Department of Justice (DOJ) telling it to stop making allegedly adulterated medicines there. Read More