[ Price : $8.95]
FDA issues a complete response letter seeking more information about Amags application for a single-dose vial of its Makena.[ Price : $8.95]
Two Covington & Burling attorneys say recent court decisions and appeals show that branded drug manufacturers are still making goo...[ Price : $8.95]
Anti-morcellator activist Hooman Noorchashm charges that CDRH director Jeffrey Shuren either experienced a critical memory lapse o...[ Price : $8.95]
CDER director Janet Woodcock says too much is being made of biosimilar interchangeability and pharmacy substitution as FDA moves t...[ Price : $8.95]
Eli Lilly and Merck extend an existing collaboration to evaluate the combination of Lillys Alimta and Mercks Keytruda in a pivotal...[ Price : $8.95]
FDA posts its fifth, sixth and seventh reports on backlogs in postmarketing reports and commitments.[ Price : $8.95]
FDA says that Merck and Pfizers avelumab is a breakthrough therapy for patients with metastatic Merkel cell carcinoma.[ Price : $8.95]
FDA makes presentations biomarkers, the benefit/risk framework, and patient-reported outcomes at a PDUFA 6 reauthorization stakeho...