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Mylan’s generic of Allergan's vaginal estrogen cream Estrace gets FDA nod

Mylan has secured the US FDA approval for Estradiol Vaginal Cream USP, 0.01%, the generic version of Allergan’s vaginal estrogen cream – Estrace for the treatment of vulvar and vaginal atrophy. Following the approval of the vaginal estrogen cream, Mylan has announced the launch of Estradiol Vaginal Cream in the US. A condition that normally […]

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Lilly’s ramucirumab fails to crack phase 3 gastric cancer trial

Eli Lilly and Company, which is better known as Lilly, says that a late-stage trial of Cyramza (ramucirumab) for the treatment of a form of gastric cancer met its primary goal of stopping the disease from advancing, but failed in improving overall survival. An antiangiogenic therapy, ramucirumab in combination with cisplatin and capecitabine or 5-FU […]

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ViiV Healthcare secures Juluca FDA approval for virologically suppressed HIV-1

Juluca FDA approval : ViiV Healthcare’s 2-drug regimen Juluca has secured approval from the US Food and Drug Administration (FDA) for the maintenance treatment of virologically suppressed human immunodeficiency virus type 1 (HIV-1) infection. The HIV drug regimen Juluca, which is intended to be taken as a single pill daily once, is a combination of […]

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Acalabrutinib wins US FDA approval for mantle cell lymphoma treatment

Acalabrutinib FDA approval : AstraZeneca has secured an early approval for its blood cancer drug Calquence (acalabrutinib) for the treatment of mantle cell lymphoma in adult patients who were subjected to a minimum of one prior therapy for the rare type of blood cancer. According to the National Cancer Institute at the National Institutes of […]

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Kite Car T therapy Yescarta bags FDA approval for type of lymphatic cancer

Yescarta FDA approval : Kite Pharma has bagged the US FDA approval for its chimeric antigen receptor T cell (CAR T) therapy Yescarta (axicabtagene ciloleucel) for a type of lymphatic cancer (Lymphoma). FDA Approves New Lymphoma Drug Yescarta The Car T therapy from the Gilead subsidiary will be available as a new treatment option in […]

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AstraZeneca lung cancer drug Tagrisso gets FDA breakthrough therapy designation

Pharma news updates : Tagrisso (osimertinib), the AstraZeneca lung cancer drug has bagged the breakthrough therapy designation (BTD) from the US FDA for the treatment of non-small cell lung cancer (NSCLC) in a first line setting. The BTD designation for the AstraZeneca cancer drug is specifically for treating metastatic NSCLC patients who have tested positive […]

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Panel recommends Luxturna FDA approval for rare form of blindness

Luxturna FDA approval news : Luxturna (voretigene neparvovec), a gene therapy from Spark Therapeutics is closing in towards an FDA approval for treating blindness due to an inherited retinal disease (IRD), following the recommendation from an advisory panel of the US drug regulator. An adeno-associated viral (AAV) vector gene therapy, Luxturna has been recommended to […]

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Novo Nordisk bags insulin aspart injection Fiasp FDA approval for diabetes

Fiasp FDA approval : Danish pharmaceutical company Novo Nordisk has secured the US FDA approval for its new fast-acting mealtime insulin aspart injection Fiasp 100 Units/mL for diabetes treatment in adults. Already approved in Canada and Europe, Fiasp is the addition of two excipients to Novo Nordisk’s insulin aspart (NovoLog) in a new formulation with […]

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Abemaciclib FDA approval : Lilly breast cancer drug gets regulatory nod

Abemaciclib FDA approval : Eli Lilly and Company (Lilly) has secured the US FDA approval for Verzenio (abemaciclib) to treat metastatic breast cancer in patients whose disease had progressed after a prior treatment. Abemaciclib FDA Approval The breast cancer drug approval is for patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 […]

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Ajanta Pharma gets USFDA approval for Entacapone, Parkinson’s disease tablet

Ajanta Pharma got the final USFDA approval for Entacapone tablets which is used for treating the Parkinson’s disease. Ajanta Pharma said that it has received the final approval for Entacapone tablets from US FDA in a BSE filing. Entacapone tablets are bioequivalent generic version of Comtan tablets. Ajanta Pharma company said that they will launch […]

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