FDA Approvals

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Advanced Melanoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an...

Boehringer Ingelheim 3rd-generation EGFR TKI, BI 1482694, receives FDA Breakthrough Therapy Designation in lung cancer

FDA Approvals

• New data from Phase I/II clinical trial presented at ESMO Asia 2015 Congress showcase the potential for BI 1482694* to become a new...

AstraZeneca receives Complete Response Letter from US FDA for saxagliptin / dapagliflozin fixed-dose-combination

Americas

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA)...

Jazz Pharmaceuticals Announces FDA Acceptance for Filing with Priority Review of NDA for Defibrotide

Americas

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted for filing with Priority Review...

Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial

Americas

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the U.S. Food and Drug Administration (FDA) requested an additional clinical study as part of...

FDA Approves Dyanavel XR

Americas

Tris Pharma Receives FDA Approval of Dyanavel XR (amphetamine) Once-Daily Liquid for ADHD in Children ("Tris") announced that the U.S. Food and Drug Administration...

FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer

Americas

The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC)...

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