You are here: Industry Insights > FDA

News List

FDA grants priority review for Bayer, Loxo Oncology's larotrectinib in TRK fusion cancers firstwordpharma
May 30, 2018
Bayer announced Tuesday that the FDA granted priority review to a marketing application submitted by partner Loxo Oncology for larotrectinib to treat adult and paediatric patients with locally advanced or metastatic solid tumours harbouring a neurotrophic
FDA demonizes pharma over generics, but most company reputations can take the blow fiercepharma
May 28, 2018
The FDA is taking pharma to the woodshed again, this time over generic drug stalling tactics. Recently, the agency published an online list of pharma companies that together have racked up 150 complaints from generics makers seeking samples.
AstraZeneca's Imfinzi survival win shores up the one lung cancer advantage it has fiercepharma
May 28, 2018
AstraZeneca’s Imfinzi already has an FDA approval in the lung cancer maintenance setting under its belt, something none of its rivals will be able to say for a while. And Friday, it hit another key benchmark to stretch out that lead.
FDA stalls Eisai—and its new partner Merck—in quest to widen cancer med Lenvima's reach fiercepharma
May 28, 2018
Merck & Co. was expecting big things from Eisai’s Lenvima in March, when it agreed to shell out up to $5.8 billion on half of the liver cancer drug’s sales. But in the first expansion bid since that deal, Lenvima has hit a snag.
BioMarin scores long-sought FDA nod for Palynziq, but its $192K launch could be tough fiercepharma
May 28, 2018
More than two years after turning in disappointing results from a phase 3 trial of Palynziq to treat the rare inherited blood disorder phenylketonuria (PKU), BioMarin finally won FDA approval for the drug Thursday night.
FDA approves AZ's Lokelma for hyperkalaemia pharmafile
May 25, 2018
The FDA has revealed its decision to approve AstraZeneca’s oral potassium-removing agent Lokelma (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia.
FDA reprimands suppliers of opioid substitute kratom products pharmafile
May 25, 2018
The ongoing opioid epidemic in the US has seen the rise of the sale and use of kratom (mitragyna speciose), a plant with opiate effects, as a means for treating opioid addiction.
Sun Pharma drug combo scoresFDA approval in advanced castration-resistant prostate cancer pharmafile
May 25, 2018
Sun Pharma is celebrating with the announcement that its CYP17 inhibitor Yonsa (abiraterone acetate) has been awarded FDA approval in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult
FDA cracks down on benzocaine teething products pharmafile
May 25, 2018
The FDA has put its foot down on over-the-counter teething products for infants and children which contain benzocaine, a pain relieving agent which has been linked to serious health risks, stressing that they are ineffective and is calling for manufacture
FDA clears Amgen’s Prolia for glucocorticoid osteoporosis pharmatimes
May 24, 2018
The decision allows physicians to prescribe the drug to patients with a history of osteoporotic fracture, those with multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 367 368 Next page