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FDA grants priority review of Nucala for patients with Hypereosinophilic Syndrome
pharmaceutical-business-review
May 29, 2020
GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has granted a priority review for the company’s application seeking approval of Nucala (mepolizumab) ...
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Biota Biosciences Recalls CBD Products
americanpharmaceuticalreview
May 29, 2020
Biota Biosciences is voluntarily recalling multiple lots of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level.
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US FDA asks five firms to recall diabetes drug with high NDMA levels
expresspharma
May 29, 2020
It named Apotex Corp as one of the firms whose metformin tablets have high levels of NDMA, but did not reveal the other four firms.
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Novaremed seeks FDA nod for evaluating NRD135S.E1 for treatment of PDPN
pharmaceutical-business-review
May 28, 2020
Novaremed is seeking the approval of the US Food and Drug Administration (FDA) to begin a phase 2 trial for evaluating its new drug candidate NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy (PDPN).
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US FDA approves Takeda’s ALUNBRIG for rare and serious form of lung cancer
pharmaceutical-business-review
May 28, 2020
Takeda Pharmaceutical Company announced that the U.S. Food and Drug Administration (FDA) approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) ...
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FDA Approves Ripretinib for Advanced Gastrointestinal Stromal Tumor
americanpharmaceuticalreview
May 28, 2020
The Food and Drug Administration (FDA) approved ripretinib (QINLOCK, Deciphera Pharmaceuticals), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
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FDA Provides Promised Transparency for Antibody Tests
americanpharmaceuticalreview
May 28, 2020
The U.S. Food and Drug Administration (FDA) posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
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FDA approves Phexxi™ vaginal gel for prevention of pregnancy
europeanpharmaceuticalreview
May 28, 2020
The US FDA approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) gel, the first non-hormonal, vaginal pH regulator contraceptive.
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US FDA approves the only drug in US to treat severe malaria
expresspharma
May 28, 2020
Prior to this approval, IV artesunate was only available to patients through the FDA’s Expanded Access program.
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Treatment for a form of bladder dysfunction in pediatric patients approved by the US FDA
expresspharma
May 28, 2020
The efficacy of VESIcare LS for the treatment of neurogenic detrusor overactivity (NDO) was established in two clinical trials with a total of 95 pediatric NDO patients, ages two to 17 years old.