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Updated data from the phase 1/II BRUIN trial of Jaypirca in patients with covalent BTK inhibitor pre-treated r/r Mantle Cell Lymphoma continue to demonstrate durable efficacy – Eli Lilly

Written by | 5 Jun 2023

A poster presentation (Abstract #7514) presented at ASCO will highlight efficacy data with a median survival follow-up time of two years for Jaypirca in relapsed or refractory MCL… read more.

Primary results of the FROZEN-AF IDE trial with the POLARx cryoablation system – Boston Scientific

Written by | 4 Jun 2023

– Primary results of the FROZEN-AF IDE trial with the POLARx Cryoablation System : Results from the global, prospective, non-randomized, single-arm FROZEN-AF IDE study of the POLARx Cryoablation… read more.

FDA approval for Inpefa to treat heart failure – Lexicon Pharma

Written by | 3 Jun 2023

Lexicon Pharmaceuticals, Inc. announced that the FDA has approved Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent… read more.

FDA approval to expand the use of HYQVIA to treat primary immunodeficiency in children – Takeda

Written by | 2 Jun 2023

Takeda announced that the FDA has approved a supplemental biologics license application (sBLA) to expand the use of HYQVIA to treat primary immunodeficiency (PI) in children 2-16 years… read more.

EU approves Rinvoq in Crohn’s disease – AbbVie

Written by | 1 Jun 2023

AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) as the first oral Janus Kinase (JAK)… read more.

Lynparza + abiraterone approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer – AstraZeneca + Merck Inc

Written by | 31 May 2023

AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or… read more.

Brixadi extended-release subcutaneous injection receives FDA approval for moderate to severe opioid use disorder – Braeburn

Written by | 30 May 2023

Braeburn announces that the FDA has approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder… read more.

New research on Otezla in psoriatic arthritis presented at EULAR 2023 – Amgen

Written by | 29 May 2023

Amgen announced new research examining the use of Otezla (apremilast) in psoriatic arthritis, including the Phase IV MOSAIC study and an exploratory analysis of cardiometabolic risk factors, which… read more.

Medtronic receives FDA expanded approval for cardiac cryoablation catheters for pediatric treatment of a common heart rhythm condition

Written by | 16 Aug 2022

Medtronic plc a global leader in healthcare technology, announced that the Freezor and Freezor Xtra Cardiac Cryoablation Catheters are approved by the FDA and are the only ablation… read more.

Positive results from phase III PRIME study of Zejula at Society of Gynecologic Oncology Meeting – Zai Lab + GSK

Written by | 7 Jul 2022

Zai Lab Limited presented data from the Phase III PRIME study of Zejula (niraparib) as maintenance therapy at the Society of Gynecologic Oncology annual meeting . Zejula demonstrated… read more.

CHMP recommends Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma – BMS

Written by | 6 Jul 2022

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the… read more.

NMPA (China) approves Paxlovid conditionally to treat COVID-19 – Pfizer

Written by | 30 Jun 2022

China’s medical products regulator has given conditional approval for Pfizer’s COVID-19 drug Paxlovid, making it the first oral pill specifically developed to treat the disease cleared in the… read more.

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