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Amneal launches Generic Abiraterone Acetate Tablets, following US FDA approval
expresspharma
January 11, 2021
They are indicated for treatment of metastatic prostate cancer.
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Cipla, Strides Pharma recall drugs in the US market
expresspharma
January 11, 2021
Cipla has recalled packets of esomeprazole magnesium for delayed-release oral suspension while Strides Pharma has recalled Tacrolimus capsules.
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Anixa, Cleveland Clinic Announce FDA Clearance to Initiate Breast Cancer Vaccine Trial
americanpharmaceuticalreview
January 08, 2021
Anixa Biosciences announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its breast cancer vaccine.
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Roche gets FDA breakthrough therapy status for tiragolumab plus Tecentriq
pharmaceutical-business-review
January 08, 2021
Roche has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for tiragolumab plus Tecentriq (atezolizumab) to treat PD-L1-high non-small cell lung cancer (NSCLC).
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CURE Pharmaceutical receives FDA approval for IND application for erectile dysfunction product CUREfilm Blue
pharmaceutical-business-review
January 08, 2021
CURE Pharmaceutical Holding, a technology focused, vertically integrated drug delivery and product development company in the pharmaceutical and health & wellness space, announced today that the U.S. Food and Drug Administration (FDA) has approved an ...
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Lupin gets tentative USFDA nod for empagliflozin and metformin hydrochloride ER tablets
expresspharma
January 08, 2021
They are indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
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FDA Approves XPOVIO for Multiple Myeloma
americanpharmaceuticalreview
January 07, 2021
Karyopharm Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved XPOVIO® (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with bortezomib and dexamethasone ...
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FDA Approves IND Application for Brain Cancer Drug Candidate
americanpharmaceuticalreview
January 07, 2021
CNS Pharmaceuticals announced the Investigational New Drug (IND) application for its lead product candidate, Berubicin, for the treatment of Glioblastoma Multiforme (GBM) is now approved and in effect as filed with the US Food and Drug Administration ...
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FDA grants ARX788 fast track designation for HER2-positive metastatic breast cancer
pharmaceutical-business-review
January 07, 2021
Ambrx announced that the US Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based ...
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Lupin gets US FDA approval for Sulfamethoxazole and Trimethoprim
expresspharma
January 07, 2021
Lupin has received the United States Food and Drug Administration approval for its Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL.