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JB Chemicals gets ANDA approval from US FDA for Loratadine Tablets expresspharma
January 12, 2021
The tablets are indicated for the treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy for OTC use.
Provention Bio Announces Teplizumab BLA for Delay or Prevention of Clinical T1D americanpharmaceuticalreview
January 11, 2021
Provention Bio announced the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA).
Amneal launches Generic Abiraterone Acetate Tablets, following US FDA approval expresspharma
January 11, 2021
They are indicated for treatment of metastatic prostate cancer.
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.
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.
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).
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 ...
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.
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 ...
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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