FDA Approvals

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

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...

FDA Approves Expanded BOTOX Label for the Treatment of Pediatric Patients with Spasticity

FDA Approvals

Allergan, an AbbVie company, announced that the U.S. FDA approved a supplemental Biologics License Application (sBLA) that supports expanded use of BOTOX® for the...

Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

FDA Approvals

AstraZeneca and MSD Inc., Kenilworth, N.J., US announced that Lynparza (olaparib) has been approved in the European Union (EU) for patients with germline BRCA-mutated...

AstraZeneca’s Farxiga scores another FDA fast-track designation

FDA Approvals

AstraZeneca’s heart failure drug Farxiga has picked up a US FDA fast-track designation (FTD) in another indication as it continues to strengthen its position...

Boehringer Ingelheim gets European approval for additional indication for nintedanib in pulmonary fibrosis

FDA Approvals

Boehringer Ingelheim announced that the EC has approved an additional indication for nintedanib in adults for the treatment of other chronic fibrosing interstitial lung...

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