Equity Bulls says FDA had two observations following its inspection at the Lupin Pithampur Unit 1 facility in India.
FDA clears a Baxter International 510(k) for the Q-NRG+, a metabolic monitoring device that uses indirect calorimetry technology to accurately measure...
FDA releases the FDA-483 with two observations from an inspection at SCA Pharmaceuticals.
Federal Register notice: FDA announces a 3/30 public meeting entitled Patient-Focused Drug Development for Vitiligo.
FDA announces a 4/20-21 workshop entitled The 12th Annual Sentinel Initiative Public Workshop.
Trevena resubmits its NDA for oliceridine for managing moderate-to-severe acute pain.
Pfizer and Astellas Pharma report study data demonstrating a statistically significant improvement in overall survival in men with non-metastatic cast...
FDA releases its latest batch of Warning Letters that includes one medical product company Marco Pharma.