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Amgen submits supplemental NDA for Otezla for adults with mild-to-moderate plaque psoriasis

Written by | 1 Mar 2021

Amgen announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Otezla (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are… read more.

Pfizer and BioNTech SE initiate a study as part of broad development plan to evaluate COVID 19 booster and new vaccine variants

Written by | 1 Mar 2021

Pfizer Inc.and BioNTech SE announced they have begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the… read more.

Voluntary withdrawal of Imfinzi indication in advanced bladder cancer in the US – AstraZeneca

Written by | 28 Feb 2021

AstraZeneca announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer. This decision was… read more.

EU approves Yuflyma for multiple chronic inflammatory diseases – Celltrion Healthcare

Written by | 28 Feb 2021

Celltrion Healthcare announced that on February 11th, the European Commission (EC) has granted marketing authorisation for Yuflyma (CT-P17), an adalimumab biosimilar, across all thirteen intended indications for the… read more.

OlympiA phase III trial of Lynparza for the treatment of BRCA-mutated high-risk HER2-negative early breast cancer will reported early – AstraZeneca + Merck Inc

Written by | 27 Feb 2021

The OlympiA Phase III trial for AstraZeneca and MSD’s Lynparza will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee (IDMC).

Health Canada approves Assure Tech Ecotest COVID-19 serological rapid test for COVID-19 – Verify Diagnostics

Written by | 26 Feb 2021

Verify Diagnostics announced that Health Canada has authorized the Assure Tech Ecotest COVID-19 serological rapid test to be used at the point-of-care (POC) for the purpose of screening… read more.

Germany, Europe’s medtech powerhouse, installs first Versius system – CMR Surgical

Written by | 25 Feb 2021

CMR Surgical (CMR) has announced the introduction of its Versius Surgical Robotic System in Germany.

Medtronic announces voluntary recall of unused Valiant Navion Thoracic stent graft system

Written by | 24 Feb 2021

Medtronic plc has voluntarily issued a global recall of unused Medtronic Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the device until… read more.

Pfizer and BioNTech submit COVID-19 vaccine stability data at standard freezer temperature to the FDA

Written by | 23 Feb 2021

Pfizer Inc. and BioNTech SE announced the submission of new data to the FDA demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F… read more.

FDA grants expanded approval for Entresto in heart failure – Novartis

Written by | 22 Feb 2021

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.

WHO gives COVID-19 Vaccine AstraZeneca Emergency Use Listing for COVID-19 – AstraZeneca

Written by | 21 Feb 2021

AstraZeneca’s COVID-19 vaccine has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunisation to prevent COVID-19 in individuals 18 years of age… read more.

FDA approves Libtayo as first immunotherapy indicated for patients with advanced basal cell carcinoma – Sanofi

Written by | 19 Feb 2021

The FDA has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) from Sanofi as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a… read more.

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