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AmSin plans to submit a request for listing of KRAS G12C inhibitors to the FDA by the end of the year
Time of Update: 2020-12-24
schedule, Amjin's Sotorasib will be approved by the FDA when Mirati's MRTX849 submits its listing application next year.
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Tumor vaccine and PD1, melanoma patients with complete remission rate of 45%! Obtained fda breakthrough therapy
Time of Update: 2020-12-24
phase I/II clinical study code-named MM1636 included 30 patients with metastasis melanoma who received the Navuliyu single anti-combined tumor vaccine IO102 and IO103 as first-line treatment.
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FDA approves oral GnRH-affected antagonist Orgovyx for the treatment of advanced prostate cancer
Time of Update: 2020-12-24
the U.S. Food and Drug Administration (FDA) recently said it has approved Myovant Sciences' GnRH-subject antagonist Orgovyx (relugolix) to treat patients with advanced prostate cancer.
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12:1! Novaral's heavy heart failure drug, Nohinto, has received support from the FDA Advisory Committee to expand its scope of application
Time of Update: 2020-12-23
Entresto has been approved in 115 countries around the world to treat reduced blood score heart failure (HFrEF).
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Zee-Pharma JAK inhibitors are eligible for FDA orphan drugs
Time of Update: 2020-12-23
path, inhibit STAT phosphorylation, and thus inhibit the downstream gene expression of STAT regulation. 2016, jactic acid jactic acid tablets were approved for clinical trials in China. According to the drug clinical trial registration
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FDA approves Takeda's ICLUSIG (ponatinib) treatment for drug-resistant or drug-resistant chronic granulocytic leukemia
Time of Update: 2020-12-22
Takeda Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved ICUSIG® (ponatinib) to treat patients with chronic granulocytic leukemia (CML) who are resistant to kinase inhibitors or are resistant to drugs.
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FDA approves immuno-optimized HER2 monoantitherapy for the treatment of metastasis HER2-positive breast cancer
Time of Update: 2020-12-22
Margenza (margetuximab-cmkb) is a monoclonal antibody optimized for Fc, targeting the HER2 protein.
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It will be the first FDA-approved therapy Takeda's innovative glucoticoid formula to be prioritized for review
Time of Update: 2020-12-22
Eosinophilic esophitis (EoE) is an immune-mediated, chronic inflammatory disease confined to the esophine that can cause damage to the esophavius and the prevalence is increasing.
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Treatment of UV-causing skin pre-cancer lesions FDA approves innovative alternative therapies
Time of Update: 2020-12-22
Athenex Announcs FDA Approval of Klisyri ® (Tirbanibulin) for The Treatment of Actinic Keratosis on Face or Scalp.
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Johnson and Johnson Amivantamab Dual Anti-Domestic Start-Up Phase III Clinical has submitted BLA to the FDA
Time of Update: 2020-12-22
Phase 1 clinical trials in 2019 on safety, PK, Exploratory Phase 2 recommended doses, and initial efficacy in patients with advanced non-small cell lung cancer. from: Insight Database () CTR20202472 is a parallel, random, double-blind
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FDA approves PHASE III clinical trial of AMZ002 for the treatment of epilepsy in infants
Time of Update: 2020-12-22
pharmaceutical company AMZELL recently announced that it has concluded discussions with the FDA and will conduct a Phase III clinical trial of AMZ002 to treat epilepsy in infants.
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The FDA has refused to approve Novaral's siRNA drug inclisiran
Time of Update: 2020-12-22
Pharmaceuticals said Friday that the FDA has issued a full response letter (CRL) to its marketing application for inclisiran, a siRNA drug for PCSK9, which is expected to be used to treat hyperlipidemia in adults with elevated LDL-cholesterol.
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HER2 targeted dual-specific antibodies were identified by the FDA as breakthrough therapy for the treatment of specific bile duct cancer patients
Time of Update: 2020-12-21
Zymeworks announced today that the FDA has awarded its human skin growth factor subjectivity 2 (HER2) targeted dual-specific antibody zandatamab breakthrough therapy for the treatment of her2 gene amplification in patients with treated bile duct cancer (BTC).
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Novarma/GenenteXolair's new adaptation is approved by the FDA for listing
Time of Update: 2020-12-20
On December 1, Roche Group member companies Genentech and Novartis Pharmaceuticals also announced that the FDA had approved a joint development and commercialization of Xolair® (omalizumab, omaju monoanti) supplemental biologics license application
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FDA accelerates approval of innovative RET inhibitor extension adaptation for the treatment of specific thyroid cancer patients
Time of Update: 2020-12-20
/> approval is based on the efficacy and safety results of a Phase 1/2 clinical trial called ARROW. in 55 treated MTC patients with RET mutations, Gavreto achieved a total remission rate (ORR) of 60%. ORR was 66% of the 29 primary MTC patients
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FDA approves first PSMA targeted PET imaging drug for prostate cancer patients
Time of Update: 2020-12-20
, the second trial showed that PET imaging based on Ga 68 PSMA-11 could detect the site of the disease in patients with relapsed prostate cancer, providing important information that could affect treatment.
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Oral FGFR inhibitors are eligible for FDA priority review for the treatment of bile tube cancer
Time of Update: 2020-12-20
BridgeBio Pharma and its subsidiary QED Therapeutics announced that the FDA has accepted a new drug application (NDA) for the oral FGFR1-3 selective inhibitor infigratinib for the treatment of patients with cholangiocarcinoma.
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New medicine for nose python! The FDA has approved Roche Xolair's new adaptive disorder, Target
Time of Update: 2020-12-19
disorder, as an additional (add-on) maintenance therapy, used to treat adult patients with nasal polyps who do not respond well to nasal corticosteroids (≥18 years old). phase III clinical data show that Xolair treatment reduces the size of nasal
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Anti-transplant new drugs! Novartis JAK inhibitor Jakavi treats steroid incurable chronic graft anti-host disease (GvHD) Phase 3 clinical success!
Time of Update: 2020-12-19
data show that oral JAK1/2 inhibitor Jakavi (ruxolitinib, Rusotinib) significantly improved a range of efficacy indicators in patients with steroid incurable/dependent chronic GvHD, including failure-free survival (FFS) and symptoms reported by patients, compared to best available therapies (BAT).
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Hereditary angioedema (HAE) the first oral therapy! FDA approves plasma kinetic peptide release enzyme inhibitor Orladeyo (berotralstat)!
Time of Update: 2020-12-19
it's worth noting that Orladeyo is the first targeted oral therapy approved to prevent HAE seizures, and its approval will make significant progress in the treatment of HAE patients and help reduce the burden of treatment for patients.
