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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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