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FDA approves Xeris ready-to-use liquid glucreatic glucemic Gvoke

 Time of Update: 2021-02-24

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Xeris Pharmaceuticals Inc. announced Tuesday that the U.S. Food and Drug Administration has approved Gwalk (gluatic glucin) for the treatment of severe hypoglycemia in children and adults 2 years of age and older with diabetes.
FDA approves first treatment for patients with rare lung disease

 Time of Update: 2021-02-24

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Recently, the U.S. Food and Drug Administration approved Gifraj to treat acute hepatodiasis in adults, a genetic disorder that can lead to the accumulation of toxic molybrene molecules formed during the production of hemoerin (which helps bind oxygen to the blood).
CHMP recommends approval of Trogarzo for multidrring-resistant TREATMENT of HIV-1

 Time of Update: 2021-02-24

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Trogarzo is the first approved single anti-drug in the field of HIV treatment, and the first long-acting new drug for HIV, unlike other antiretroviral drugs, which are mainly combined with the second extracellular domain of CD4-T cellular mediators, far from the MHC II molecular binding site, which can potentially prevent HIV from infecting CD4-plus immune cells while retaining normal immune function.
Gilead published clinical data on GS-9688, a new functional drug for hepatitis B

 Time of Update: 2021-02-24

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In a multi-center, randomized, double-blind Phase II study of 48 patients with chronic HBV infections who had achieved virological suppression, GS-9688 (once a week oral) combined oral antiviral drugs (OAVs) were well toned during extended administration and showed pharmacological activity of dose dependence.
The FDA has awarded AstraZeneta Imfinzi an orphan drug to treat small cell lung cancer

 Time of Update: 2021-02-24

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Based on this result, Imfinzi became the first immunotherapy to be shown to have a three-year survival benefit in the non-excisive Phase III NSCLC population.
Xofluza: An effective anti-flu drug

 Time of Update: 2021-02-24

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. Roche announced that in the IIIBLOCKSTONE study, the risk of influenza was significantly reduced by 86% compared to placebo, using Xofluza for preventive treatment after contact with infected family members.
FDA approves new treatment for migraines in adults

 Time of Update: 2021-02-24

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U.S. Food and Drug Administration recently approved Ubrivevy tablets for acute (immediate) treatment of migraines in adults, with or without precursors (sensory phenomena or visual impairments), and Ubrelvy was not used to prevent migraines.
FDA approves Red Hill's innovative therapy, Talicia, for listing

 Time of Update: 2021-02-24

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today, Red Hill Biopharma announced that the U.S. FDA has approved the listing of its innovative therapy, Talicia, to treat adult patients infected with Helicobacter pyridosis. Talicia is an FDA-approved helicobacter pyridobacteria removal therapy based on rifabutin designed to address helicobacter pyridosis resistance to antibiotics commonly used in standard care therapies.
Rinvoq has been approved by the European Union to treat rheumatoid arthritis

 Time of Update: 2021-02-24

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Professor Andrew Cope, director of the Rheumatology Centre at King's College London, said the results of the studies meant that patients with active diseases had another treatment option with acceptable safety, which could lead to disease relief even if they did not respond adequately to drugs such as methotrexate or anti-tumor necrotizing factors.
AstraZenecon Calquence first-line treatment CLL III clinical success

 Time of Update: 2021-02-24

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ELEVATE-TN (ACE-CL-007) is a randomized, multi-center, open-label Phase III study conducted in patients with previously un treated (primary treatment) CLL to assess the efficacy and safety of Calquence monotherapy, Calquence-obinutuzumab combination therapy and benzodiazepine nitrogen mustard-outuzumab combination therapy.
Breyanzi, the CAR-T cell therapy of Shishi Shiguibo, has been approved by the FDA

 Time of Update: 2021-02-24

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, the U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb's CD19 CAR-T cell therapy, Breyanzi (lisocabtagene maraleucel, liso-cel) for the treatment of adult patients with recurring or incurable large B-cell lymphoma treated in two or more systemic treatments.
The FDA accepts Mercedon's update of Keytruda's dosing frequency

 Time of Update: 2021-02-24

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Specifically: every 6 weeks 400 mg intravenous infusion, infusion time is not less than 30 minutes, for Keytruda's 6 tumor adaptations: melanoma, classic Hodgkin lymphoma, primary vertical large B cell lymphoma, stomach cancer, hepatocellular cancer, Merkel cell carcinoma.
Novaral's sickle cell drug gets FDA priority review

 Time of Update: 2021-02-24

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The regulatory agency accepted the company's Biologics Licensing Application (BLA) for the prevention of vascular ococcytosis (VOCs) in patients with sickle cell disease (SCD) and was awarded a breakthrough treatment designation in December 2018.
Researchers have uncovered experimental compounds to block treatment targets for blood cancer

 Time of Update: 2021-02-24

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“ We found a protein called Tyro3 that was highly increased to a non-Hodgkin's lymphoma subtype, called primary fluid lymphoma," said Dr. Blossom Damania, an associate researcher at the UNC Lineberger School of Medicine, a distinguished professor of microbiology and immunology at Cary C.
FDA approves new drugs for the treatment of tuberculosis, a form of lung resistance

 Time of Update: 2021-02-24

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That's why in our other efforts to address antimicrobial resistance, we focus on promoting the development of safe and effective new therapies that give patients more options to fight life-threatening infections.
GSK's Dovato reached the end of the study

 Time of Update: 2021-02-24

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earlier this year, Dovato monoliths were licensed in the United States to treat hiv-1 infections in adults with no history of antiretroviral therapy and no known resistance to dolutegravir or lamifding.
EMA accepts license extensions from Invokana and Vokanamet

 Time of Update: 2021-02-24

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Mundipharma announced that the European Medicines Agency (EMA) had received a deferred licence from Invokana and Vokanamet (canagliflozin and metformin) for the treatment of stage 2 or stage 3 chronic kidney disease (CKD) and albuminuria as standard assisted type 2 diabetes patients.
FDA approves new add-ons for the treatment of Parkinson's disease in adults

 Time of Update: 2021-02-24

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“ Parkinson's disease is a debilitating disease that severely affects a patient's life," said Eric Bastings, acting director of neurology products at the FDA's Center for Drug Evaluation and Research.
The FDA has approved Bayer nubeqa ® for the treatment of patients with adenocarcinoma

 Time of Update: 2021-02-24

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today, Bayer announced FDA approval for Nubeqa® (darolutamide) for the treatment of patients with non-metastatic desopathic prostate cancer (nmCRPC). Bayer has the right to commercialize the drug globally, and Orion has the option to co-promote the product in Europe.
Green leaf pharmaceutical high-dose Liss' permeable skin patch has been approved for sale in Germany

 Time of Update: 2021-02-24

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's single-day permeable patch for the treatment of Alzheimer's disease is one of the core products of Leafy Pharmaceuticals in the central nervous field. Green leaf pharmaceutical's Liss's single-day permeable patch was developed by its German subsidiary, Luye Pharma AG, on the research and development platform for permeable drugs.

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Medical Science News

FDA approves Xeris ready-to-use liquid glucreatic glucemic Gvoke

FDA approves first treatment for patients with rare lung disease

CHMP recommends approval of Trogarzo for multidrring-resistant TREATMENT of HIV-1

Gilead published clinical data on GS-9688, a new functional drug for hepatitis B

The FDA has awarded AstraZeneta Imfinzi an orphan drug to treat small cell lung cancer

Xofluza: An effective anti-flu drug

FDA approves new treatment for migraines in adults

FDA approves Red Hill's innovative therapy, Talicia, for listing

Rinvoq has been approved by the European Union to treat rheumatoid arthritis

AstraZenecon Calquence first-line treatment CLL III clinical success

Breyanzi, the CAR-T cell therapy of Shishi Shiguibo, has been approved by the FDA

The FDA accepts Mercedon's update of Keytruda's dosing frequency

Novaral's sickle cell drug gets FDA priority review

Researchers have uncovered experimental compounds to block treatment targets for blood cancer

FDA approves new drugs for the treatment of tuberculosis, a form of lung resistance

GSK's Dovato reached the end of the study

EMA accepts license extensions from Invokana and Vokanamet

FDA approves new add-ons for the treatment of Parkinson's disease in adults

The FDA has approved Bayer nubeqa ® for the treatment of patients with adenocarcinoma

Green leaf pharmaceutical high-dose Liss' permeable skin patch has been approved for sale in Germany