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  US FDA grants Fast Track designation to Ideaya Biosciences’ IDE161 to treat pretreated, advanced or metastatic HR+, Her2-, BRCA1/2 mutant breast cancer,   September 28, 2023
  Alfasigma to buy Intercept Pharma for $19 per share in cash,   September 28, 2023
  US FDA grants fast track designation to Mythic Therapeutics’ MYTX-011 for patients with NSCLC with cMET overexpression,   September 27, 2023
  Biora Therapeutics submits IND application to US FDA for BT-600 programme to treat moderate to severe ulcerative colitis,   September 27, 2023
  US FDA accepts for Priority Review the sBLA for Dupixent to treat eosinophilic esophagitis in children aged 1 to 11,   September 27, 2023
  Ardelyx partner Kyowa Kirin gets Japanese approval for tenapanor for hyperphosphatemia in adult patients with CKD on dialysis,   September 26, 2023
  Novartis confirms 100% Spin-off of Sandoz business on October 4, 2023,   September 26, 2023
  BioArctic’s partner Eisai receives Japanese approval for Leqembi for the treatment of Alzheimer’s disease,   September 26, 2023
  Chugai obtains Japanese approval for Phesgo, the fixed-dose subcutaneous combination of Perjeta & Herceptin for HER2-positive breast and colorectal cancer,   September 26, 2023
  China NMPA approves Henlius' novel anti-PD-1 mAb, Hansizhuang for treatment of ESCC,   September 25, 2023
  Abbott completes acquisition of Bigfoot Biomedical,   September 25, 2023
  Eli Lilly & Boehringer Ingelheim announce US FDA approves Jardiance to treat adults with chronic kidney disease,   September 25, 2023
  Amgen launches Partners of Choice network of eight leading oncology academic centres,   September 23, 2023
  US FDA grants priority review to Merck’s sBLA for Keytruda plus concurrent chemoradiotherapy to treat patients with newly diagnosed high-risk locally advanced cervical cancer,   September 23, 2023
  China NMPA recommends priority review for Everest Medicines’ cefepime-taniborbactam to treat complicated urinary tract infections, including pyelonephritis,   September 21, 2023
  Alexion completes purchase and licence agreement for early-stage rare disease gene therapy portfolio from Pfizer,   September 21, 2023
  US FDA accepts for priority review Merck’s sNDA for Welireg in certain previously treated patients with advanced RCC,   September 21, 2023
  ViiV Healthcare’s Apretude receives European approval for HIV prevention,   September 21, 2023
  US FDA accepts for priority review Merck’s sBLA for Keytruda plus concurrent chemoradiotherapy to treat newly diagnosed high-risk locally advanced cervical cancer,   September 21, 2023
  Orexo submits NDA to US FDA for OX124, a high-dose rescue medication for opioid overdose with nasal delivery,   September 20, 2023

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