FDA accepts REGEN-COV for priority review for treatment and prophylaxis of COVID-19 – Regeneron Pharma

Regeneron Pharmaceuticals, Inc. has announced that the FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The FDA has assigned a target action date of April 13, 2022 and informed us that they currently are planning to hold an advisory committee […]

FDA approves Keytruda to treat high-risk early-stage triple-negative breast cancer – Merck Inc.

Merck Inc. announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase III KEYNOTE-522 trial. TNBC is an aggressive type of breast cancer with an […]

FDA approves Opdivo as adjuvant treatment in oesophageal or gastroesophageal junction cancer – BMS

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FDA grants priority review to Keytruda + Lenvima for advanced endometrial carcinoma – Merck Inc + Eisai

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FDA approves Keytruda + Herceptin in HER2-positive gastric or gastroesophageal junction adenocarcinoma – Merck Inc.

Merck Inc announced that the FDA has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for […]

FDA grants accelerated approval for Jemperli in endometrial cancer – GSK

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FDA approves Trodelvy, the first treatment for metastatic triple-negative breast cancer shown to improve progression-free survival and overall survival – Gilead Sciences

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FibroGen provides additional information on roxadustat to the FDA relating to U.S. primary cardiovascular safety analyses

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FDA approves Zegalogue for severe hypoglycemia in pediatric and adult patients with diabetes – Zealand Pharma

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FDA approves supplemental NDA for Exparel for postsurgical local analgesia in pediatric patients – Pacira BioSciences

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