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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.

EU approves Oxbryta for hemolytic anemia due to sickle cell disease – Global Blood Therapeutics

Written by | 29 Jun 2022

Global Blood Therapeutics announced the European Commission (EC) has granted Marketing Authorization for Oxbryta (voxelotor) for the treatment of hemolytic anemia due to sickle cell disease (SCD) in… read more.

Approval of Zynrelef by Health Canada for the management of postoperative pain – Heron Therapeutics

Written by | 28 Jun 2022

Heron Therapeutics, Inc., announced that Health Canada has issued a Notice of Compliance (NOC) to commercialize Zynrelef (bupivacaine and meloxicam extended-release solution) for instillation into the surgical wound… read more.

FDA accepts for review supplemental application for Abrilada interchangeability – Pfizer

Written by | 5 Jun 2022

Pfizer Inc. announced that the FDA has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Abrilada (adalimumab-afzb) as an interchangeable biosimilar… read more.

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