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European Commission approves Estelle oral contraceptive – Mithra

Written by | 28 May 2021

Mithra, a company dedicated to Women’s Health, is very pleased to announce that the European Commission has accepted the registration application for the novel combined oral contraceptive Estelle…. read more.

Myovant Sciences receives positive CHMP opinion for Ryeqo (relugolix combination tablet) for the treatment of women with uterine fibroids

Written by | 27 May 2021

Myovant Sciences announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of Ryeqo (relugolix… read more.

Real world study of SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Aortic Valve Replacement shows positive outcomes in aortic stenosis – Edwards Lifesciences

Written by | 26 May 2021

Edwards Lifesciences announced the results of a real-world study comparing outcomes for patients with bicuspid aortic stenosis (AS) who were treated with SAPIEN 3 and SAPIEN 3 Ultra… read more.

CHMP recommends approval of Klisyri for actinic keratosis – Almirall

Written by | 25 May 2021

Almirall S.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the regulatory approval… read more.

Real world study of Halaven in breast cancer published in Advances in Therapy – Eisai

Written by | 24 May 2021

Eisai announced results from a real-world study assessing treatment patterns and clinical outcomes with Halaven (eribulin mesylate) injection as a third-line therapy or greater in patients with metastatic… 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.

AstraZeneca COVID-19 vaccine Vaxzevria authorised for emergency use in Japan

Written by | 22 May 2021

AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, has been granted a special approval for emergency use in Japan for active immunisation of individuals aged 18 years and… read more.

Heron Therapeutics announces FDA approval of Zynrelef for the management of postoperative pain for up to 72 hours

Written by | 21 May 2021

Heron Therapeutics, Inc. announced that the FDA has approved Zynrelef (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical… 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.

Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic NSCLC – Roche

Written by | 19 May 2021

Roche has announced that the European Commission has approved Tecentriq (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have… read more.

FDA expands approval of Comirnaty for young people with COVID-19 – Pfizer and BioNTech

Written by | 18 May 2021

Pfizer and BioNTech SE announced that the FDA has expanded the Emergency Use Authorization (EUA) for their Comirnaty COVID-19 vaccine to include individuals 12 to 15 years of… 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.

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