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A drug that treats alcoholism may be the next anti-anxiety medication

Written by | 16 Apr 2022

Alcoholism, if left untreated, could have dangerous repercussions. Thus, it is no surprise that there are a range of drugs developed to treat this condition. Of these drugs,… read more.

Pfizer and BioNTech receive first FDA Emergency Use Authorization of a COVID-19 vaccine booster

Written by | 20 Oct 2021

Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age… read more.

FDA accepts REGEN-COV for priority review for treatment and prophylaxis of COVID-19 – Regeneron Pharma

Written by | 17 Oct 2021

Regeneron Pharmaceuticals, Inc. has announced that the FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized… read more.

FDA approves Keytruda to treat high-risk early-stage triple-negative breast cancer – Merck Inc.

Written by | 9 Aug 2021

Merck Inc. announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy… read more.

FDA accepts Alymsys filing for metastatic colorectal cancer – Amneal Pharma

Written by | 27 Jun 2021

Amneal Pharmaceuticals announced the FDA has accepted for review the Biologics License Application (BLA) for bevacizumab biosimilar for the treatment of metastatic colorectal cancer, in combination with intravenous… read more.

FDA grants accelerated approval for Aduhelm to treat Alzheimer’s disease – Biogen + Eisai

Written by | 15 Jun 2021

Biogen and Eisai, Co., Ltd. announced that the FDA has granted accelerated approval for Aduhelm (aducanumab-avwa) as the first and only Alzheimer’sdisease treatment to address a defining pathology… read more.

FDA approves Opdivo as adjuvant treatment in oesophageal or gastroesophageal junction cancer – BMS

Written by | 23 May 2021

Bristol Myers Squibb announced that the FDA has approved Opdivo (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer… read more.

FDA grants priority review to Keytruda + Lenvima for advanced endometrial carcinoma – Merck Inc + Eisai

Written by | 20 May 2021

Merck Inc and Eisai announced that the FDA has accepted and granted priority review for an application seeking new approval for the combination of Keytruda (pembrolizumab) plus Lenvima… read more.

FDA approves Keytruda + Herceptin in HER2-positive gastric or gastroesophageal junction adenocarcinoma – Merck Inc.

Written by | 16 May 2021

Merck Inc announced that the FDA has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients… read more.

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.

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