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Nucala (mepolizumab) gains FDA approval for two new self-administration options

GlaxoSmithKline (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate.

June 7th, 2019|News|

FDA approval for Novartis’ Piqray

Novartis’ Piqray (alpelisib) has been approved by the US Food and Drug Administration (FDA) in combination with fulvestrant for the treatment of postmenopausal women and men with HR+ and HER2- PIK3CA-mutated, advanced or metastatic breast cancer.

May 28th, 2019|News|

FDA approval for Bavencio combo in advanced RCC

The US Food and Drug Administration (FDA) has approved Merck’s Bavencio (avelumab) plus Inlyta (axitinib) combination for patients with advanced renal cell carcinoma.

May 15th, 2019|News|

ViiV submits NDA for first long-acting, injectable HIV combo

ViiV Healthcare has submitted a new drug application to the US Food and Drug Administration (FDA) for the first ever monthly, injectable, two-drug regimen of cabotegravir and Edurant (rilpivirine) for treatment of HIV.

May 1st, 2019|News|

Bayer, Orion win FDA priority review for darolutamide in prostate cancer

The US Food and Drug Administration (FDA) has accepted a new drug application for review and granted priority review for darolutamide.

May 1st, 2019|News|

FDA approves nasal spray for treatment-resistant depression

The US Food and Drug Administration (FDA) has approved Spravato (esketamine), a new nasal spray medication for treatment-resistant depression.

March 7th, 2019|News|

FDA hits leukemia study with partial clinical hold

The drug is a bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia, along with other CD123-expressing haematologic malignancies.

February 22nd, 2019|News|

Spravato gets FDA Advisory Committee approval

The decision came down to 14 yes votes, two no votes and one abstain, basing their support on the safety and efficacy data from five Phase III studies in patients with treatment-resistant depression: three short-term studies; one maintenance of effect study; and one long-term safety study.

February 13th, 2019|News|

FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder

The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting.

February 6th, 2019|News|

FDA approves first generic Advair Diskus

The U.S. Food and Drug Administration approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

January 31st, 2019|News|