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Cassiopea submits a new mechanism acne therapy application to fda
Time of Update: 2021-02-24
today, cassiopea, which specializes in developing new mechanism dermatology therapies, announced that it has submitted a new drug application (nda) to fda for the treatment of acne for its "first-in-class" local androgen inhibitor, clascoterone 1% cream.
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Genfit's double agonist was awarded orphan drug status by the FDA and EMA
Time of Update: 2021-02-24
April 2019, the FDA also awarded Elafibranor Breakthrough Drug Qualification (BTD) for the treatment of adult PBC patients who did not respond well to UDCA.
Genfit plans to launch Phase III clinical studies in 2019 to further evaluate the efficacy and safety of elafibranor's treatment of PBC.
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FDA approves new treatments for complex urinary tract and complex celiac infections
Time of Update: 2021-02-24
The U.S. Food and Drug Administration has approved Recarbrio (aamine pernam, sestatins, and relebactam), an antibacterial drug product used to treat adult patients with complex urinary tract infections (cUTI) and intracarosis infections (cIAI).
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FDA approves new treatment for migraines in adults
Time of Update: 2021-02-24
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.
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The ground-breaking PCSK9-targeted RNAi drug inclisiran III was successfully studied
Time of Update: 2021-02-24
This is the second of three key Phase III clinical studies (ORION-9, ORION-10, ORION-11) of the drug, which showed that 300mg inclisiran was given 2 subsurfic injections a year, reaching all major and secondary endpoints, with good tolerance and safety.
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FDA approves first treatment for patients with rare lung disease
Time of Update: 2021-02-24
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).
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The FDA has awarded AstraZeneta Imfinzi an orphan drug to treat small cell lung cancer
Time of Update: 2021-02-24
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.
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CHMP recommends approval of Trogarzo for multidrring-resistant TREATMENT of HIV-1
Time of Update: 2021-02-24
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.
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The FDA accepts applications for new drugs to treat multiple sclerosis
Time of Update: 2021-02-24
recently, Celgene announced that the FDA has accepted a new drug application (NDA) for Ozanimod's treatment of multiple sclerosis (RMS), and the European Medicines Agency (EMA) has accepted a market license (MAA) for ozanimod's treatment of relapsed relapsed multiple sclerosis (RRMS).
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Xofluza: An effective anti-flu drug
Time of Update: 2021-02-24
. 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.
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GSK submits a application for a new drug for daprodustat to MHLW Japan
Time of Update: 2021-02-24
recently, GlaxoSmithKline (gsk) submitted a new drug application (nda) to japan's Ministry of Health, Labour and Welfare (mhlw) for approval of oral hypooxygenated factor proline hydroxygen inhibitor (hif-phi) daprodustat to treat renal anemia caused by chronic kidney disease (ckd).
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FDA approves Xeris ready-to-use liquid glucreatic glucemic Gvoke
Time of Update: 2021-02-24
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.
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FDA approves first treatment of patients with rare blood diseases
Time of Update: 2021-02-24
recently, the U.S. Food and Drug Administration approved luspatercept-aamt treatment for adults who require routine red blood cell infusions β “ When a patient receives multiple blood transfusions, there is a risk of iron overload, which affects many organs," said Dr. Richard Pazdur, director of the FDA Center of Excellence in Oncology and acting director of the U.S. Food and Drug Administration's Office of Oncology at the Center for Drug Evaluation and Research.
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Takeda protease inhibitor Ninlaro Phase 3 test reached the main end of the test
Time of Update: 2021-02-24
Today, Takeda announced that its protease inhibitor Ninlaro (ixazomib) as a first-line maintenance therapy, in the treatment of adult patients with multiple myeloma (MM) who have not received stem cell transplant therapy in phase 3 trials, the patient's progression-free survival (PFS) has been significantly improved to reach the main end of the trial.
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Novart confirms The long-term efficacy and safety of Emwave
Time of Update: 2021-02-24
new data from Novarma confirm the long-term efficacy and safety of erenumab for most people with seizure migraines. The pharmaceutical giant announced the results of a five-year open-label treatme
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Ardelyx's Phase 3 trial to treat high phosphorusemia has reached its end
Time of Update: 2021-02-24
Once approved, Tenapanor could be the basic therapy for patients on CKD dialysis with elevated blood phosphorus concentrations, Ardelyx said.
Although these patients were treated with stable phosphate adhesives, blood phosphorus concentrations were ≥5.5 mg/dL at screening and ≤10.0 mg/dL.
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A breakthrough has been made in the Johnson and Johnson respiratory syncytial virus vaccine
Time of Update: 2021-02-24
Johnson and Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a breakthrough treatment designated as a research preventive vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract diseases in adults 60 years of age or older.
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Gilead published clinical data on GS-9688, a new functional drug for hepatitis B
Time of Update: 2021-02-24
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.
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The new AstraZeneca drug for lupus erythematosus has reached the clinical end of Phase 3
Time of Update: 2021-02-24
today, AstraZeneca announced that its use in the treatment of systemic lupus (systemic lupus erythematosus, SLE) in the study of mono-anti-drug anifrolumab, in the critical Phase 3 clinical trial TULIP 2, achieved a significant improvement in the main endpoint of the disease.
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Turalio, a new drug used to treat tendon cytoblastoma, has been approved by the FDA for the first time
Time of Update: 2021-02-24
the U.S. Food and Drug Administration (FDA) approved Dayichi Sankyo's Pexidartinib capsule for the treatment of adult patients with tendon cytomoma (TGCT) symptoms, who are associated with severe morbidity or functional limitations and have not improved through surgery.
