FDA Approvals

Novartis announced that the European Commission (EC) has approved Adakveo (crizanlizumab) for the prevention of recurrent vaso-occlusive crises (VOCs), or pain crises, in patients...

FDA Approves Expanded Indication for Merck’s KEYTRUDA in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

FDA Approvals

Merck, known as MSD outside the United States and Canada, announced that the U.S. FDA has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1...

Blueprint and Roche Take on Lilly As FDA Approves RET-Targeting Lung Cancer Drug

FDA Approvals

Cancer drugs firm Blueprint Medicines has gained a second US approval, with its Gavreto (pralsetinib) daily pill that targets non-small cell lung cancer with...

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer

FDA Approvals

Roche announced U.S. FDA approval for the expanded use of CINtec® PLUS Cytology, the first triage test based on biomarker technology for women whose...

Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trial of STI-1499 Neutralizing Antibody in COVID-19 Positive Patients

FDA Approvals

Sorrento Therapeutics, Inc. announced that it received a study may proceed letter from the FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499)...

Merck’s KEYTRUDA Receives Two New Approvals in Japan

FDA Approvals

Merck , known as MSD outside the United States and Canada, announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the...

Gileads Kite bags second CAR-T okay with Tecartus nod in mantle cell lymphoma

FDA Approvals

Kite, a Gilead Company announced that the U.S. FDA has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved...

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