Galemed recalls (Class 1) its Babi.Plus Pressure Relief Manifold system due to complaints about the device not holding pressure.
FDA accepts for review a Chiasma NDA resubmission for Mycapssa (octreotide) capsules for the maintenance treatment of adults with acromegaly.
FDA accepts for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with bevacizumab for the maintenance treatment ...
FDA Review posts the Federal Register notices for the week ending 1/10/2020.
FDA releases a draft guidance on Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters Premarket Notification (510(k)) Submi...
FDA issues SCA Pharmaceuticals a six-observation Form 483 after a November inspection cited GMP issues at the drug outsourcing facility.
A year after Bayer stopped selling and distributing its Essure implantable contraceptive device, CDRH director Jeff Shuren says Bayer has repossessed ...