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Protected: FDA grants accelerated approval for Jemperli in endometrial cancer – GSK

Written by | 1 May 2021

There is no excerpt because this is a protected post.

FDA approves Trodelvy, the first treatment for metastatic triple-negative breast cancer shown to improve progression-free survival and overall survival – Gilead Sciences

Written by | 18 Apr 2021

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 provides additional information on roxadustat to the FDA relating to U.S. primary cardiovascular safety analyses

Written by | 17 Apr 2021

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.

FDA approves Zegalogue for severe hypoglycemia in pediatric and adult patients with diabetes – Zealand Pharma

Written by | 8 Apr 2021

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.

FDA approves supplemental NDA for Exparel for postsurgical local analgesia in pediatric patients – Pacira BioSciences

Written by | 29 Mar 2021

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.

FDA approves Azstarys to treat attention deficit hyperactivity disorder – Kem Pharma Inc

Written by | 15 Mar 2021

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.

FDA approves Yescarta to treat relapsed or refractory follicular lymphoma after two lines of systemic therapy – Kite/Gilead Sciences

Written by | 13 Mar 2021

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.

FDA expands approval of Lorbrena as first line treatment of metastatic NSCLC – Pfizer

Written by | 12 Mar 2021

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.

The FDA will convene an Advisory Committee meeting to review the NDA for roxadustat to treat anemia of CKD – AstraZeneca + FIbroGen Inc

Written by | 7 Mar 2021

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.

FDA approves Pepaxto for patients with relapsed or refractory multiple myeloma – Oncopeptides AB

Written by | 6 Mar 2021

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 provides update on FDA interactions regarding an appeal denied letter relating to veverimer and metabolic acidosis

Written by | 3 Mar 2021

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.

TicoVac filed with FDA for tick-borne encephalitis – Pfizer

Written by | 2 Mar 2021

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.

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