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FDA approves Dupixent as add-on treatment for moderate-to-severe asthma – Sanofi + Regeneron

Written by | 8 Jan 2022

The FDA has approved Dupixent (dupilumab), from Sanofi + Regeneron, as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an… read more.

FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV – ViiV HealthCare

Written by | 7 Jan 2022

ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has announced it has made a regulatory submission to the… read more.

Two phase III studies of Xiaflex show efficacy in Peyronie’s disease – Endo International

Written by | 6 Jan 2022

Endo International announced that new post-hoc data from two Phase III studies of Xiaflex (collagenase clostridium histolyticum, or CCH) in treating men with Peyronie’s disease (PD) will be… read more.

Cibinqo recommended for approval by CHMP for atopic dermatitis – Pfizer

Written by | 4 Jan 2022

Pfizer announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the 100 mg and 200 mg… read more.

Booster of COVID-19 vaccine administered six months after two-dose regimen of BNT162b2, shows substantial increase in antibody and T-cell responses – Johnson & Johnson

Written by | 3 Jan 2022

Johnson & Johnson announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al…. read more.

Nucala is the first and only anti-IL-5 add-on treatment approved in Canada that targets eosinophilic inflammation in adults with chronic rhinosinusitis with nasal polyps – GSK

Written by | 2 Jan 2022

Nucala (mepolizumab) is now approved in Canada as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled… read more.

COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States – Roche

Written by | 31 Dec 2021

Roche has announced that the FDA has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test. The test uses a simple anterior nasal swab sample that can… read more.

ChemoCentryx announces approval in Japan of Tavneos for the treatment of ANCA-associated vasculitis

Written by | 26 Dec 2021

ChemoCentryx, Inc., announced that Kissei Pharmaceutical Co., Ltd. has received approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW) to market Tavneos™ (avacopan), an orally administered… read more.

FDA approves Tecartus for B-cell precursor acute lymphoblastic leukemia – Kite

Written by | 21 Dec 2021

Kite announced the FDA has granted approval for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute… read more.

European Commission approves Ronapreve to treat of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation

Written by | 18 Dec 2021

Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the European… read more.

Opdivo + Yervoy demonstrates durable overall survival at three years compared to chemotherapy in first-line unresectable malignant pleural mesothelioma – BMS

Written by | 15 Dec 2021

– Bristol Myers Squibb announced three-year data from the CheckMate -743 trial that demonstrated a durable survival benefit with first-line treatment with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared… read more.

Wegovy demonstrated significant and sustained weight loss in two-year study in adults with obesity – Novo Nordisk

Written by | 14 Dec 2021

Results from the STEP 5 phase IIIb trial, presented by Novo Nordisk at the Obesity Week 2021 interactive congress, showed that adults treated with Wegovy (semaglutide 2.4 mg… read more.

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