Gilead Sciences, Inc. announced that the FDA has granted full approval to Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)… read more.
FibroGen, Inc. has provided clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase III program for the treatment of anemia of chronic… read more.
Zealand Pharma announced that the FDA has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and… read more.
Pacira BioSciences, Inc. announced the FDA has approved the submission of its supplemental new drug application (sNDA) seeking expansion of the Exparel label to include use in patients… read more.
KemPharm, Inc. has announced that the FDA has approved the New Drug Application for Azstarys (formerly referred to as KP 415), a once-daily product for the treatment of… read more.
Kite, a Gilead Company announced that the FDA has granted accelerated approval to Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma… read more.
The FDA approved Pfizer Inc.’s supplemental New Drug Application (sNDA) for Lorbrena (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small… read more.
AstraZeneca and FibroGen, Inc. announced that the FDA informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new… read more.
Oncopeptides AB (publ) – announced that the FDA, has approved Pepaxto (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, for the treatment of adult patients with… read more.
Tricida, Inc. provided an update on its FDA interactions. Tricida has received an Appeal Denied Letter (ADL), from the Office of New Drugs (OND) of the FDA in… read more.
Pfizer announced that the FDA accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac, its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE… read more.
The FDA has approved an expanded indication for Entresto (sacubitril/valsartan), from Novartis, to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with… read more.
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