Company Name
Drug
Event
Outcome
Details
United Therapeutics Corp
(UTHR)
Tyvaso DPI (NDA)
Oct 2021
FDA decision on Tyvaso DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease
FDA issued a Complete Response Letter for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease on Oct.15, 2021-
MannKind Corp.
(MNKD)
Tyvaso DPI (NDA)
Oct 2021
FDA decision on Tyvaso DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease
FDA issued a Complete Response Letter for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease on Oct.15, 2021-
Gilead Sciences Inc.
(GILD)
Tecartus (sBLA)
10/01/2021
FDA decision on Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia
FDA approves Tecartus for adults with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia on Oct. 1,2021-
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