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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|

FDA accepts Allergan’s Vraylar for review

The US Food and Drug Administration has accepted for review an application from Allergan to expand the scope of its antipsychotic Vraylar.

September 27th, 2018|News|