Tag:
FDA delay
Latest Headlines
Latest Headlines
FDA wants new study for Atritech's LAA-closure device
Atritech will have to conduct another study of its Watchman left atrial appendage closure technology before the FDA will grant it approval, the devicemaker reveals in a statement. The Watchman is a
MannKind's inhaled insulin drug Afrezza delayed
MannKind's much-watched inhaled insulin product Afrezza has received a complete response letter from the FDA. According to a release, the letter requests more information related to several areas of
FDA delays Amylin's Byetta LAR
Amylin, Eli Lilly and Alkermes have received an FDA complete response letter for Bydureon, but the companies note in an announcement that there are no requests for new pre-clinical or clinical
FDA puts Cadence pain drug app on hold
The FDA has put Cadence Pharma's application to market its pain and fever therapy on hold. The agency alerted Cadence that it couldn't approve the drug--to be marketed as Ofirmev--until manufacturing
Incomplete plant inspections prevent Zuplenz approval
Unable to complete necessary plant inspections in India, Strativa Pharmaceuticals and Par Pharmaceuticals said today that the FDA couldn't approve the NDA for Zuplenz (ondansetron). The drug is an
Mannkind hit with insulin inhaler delay
The FDA said today that it will miss the January 16 deadline for MannKind's much-watched inhaled insulin drug Afrezza. The agency says it needs more time to complete its inspection of the insulin
FDA hesitates on Cephalon's jet lag drug
The FDA has delayed approval of Cephalon's Nuvigil for jet lag by three months, saying it needs more time to review the company's application before it can approve an additional indication. Nuvigil
FDA extends review for pain drug
The FDA wants more time to review the NDA for Exalgo, a pain drug to be sold by Mallinckrodt, and has extended the Prescription Drug User Fee Act date three months to Feb. 22, 2010. The FDA's
FDA extends Cadence drug review
Saying it needs more time to evaluate pharmacological data, the FDA has extended the review period for Cadence Pharmaceuticals' Acetavance until February 2010. The original PDUFA data was today.
Transcept shares battered after FDA denies Intermezzo OK
The FDA handed Transcept Pharmaceuticals some bitter news, denying approval of its sleep drug Intermezzo and asking for the kind of data that may require one or more new safety studies. Investors
