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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.

TGA in Australia has granted provisional registration for Spikevax COVID 19 vaccine for children aged 6-11 years old – Moderna

Written by | 28 Feb 2022

Moderna, Inc., announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a 50 µg… read more.

UK rolls out new drug approval pathway

Written by | 12 Feb 2022

Effective 1 January 2022 Pharmaceutical companies can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). The new approval… 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.

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.

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.

Moderna provides update on timing of U.S. Emergency Use Authorization of its COVID-19 Vaccine for adolescents

Written by | 4 Nov 2021

Moderna, Inc. provided an update that the FDA has notified the Company that it will require additional time to complete its assessment of Moderna’s Emergency Use Authorization (EUA)… read more.

Pfizer and BioNTech receive first USA emergency use authorization of a COVID 19 vaccine for children ages 5-11

Written by | 3 Nov 2021

Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred… read more.

Moderna announces positive top line data from phase II/III study of COVID-19 vaccine in children 6 to 11

Written by | 31 Oct 2021

-Moderna Inc. announced positive interim data from the Phase II/III study, called the KidCOVE study, of mRNA-1273 , the Company’s vaccine candidate against COVID-19, in children 6 to… read more.

FDA Advisory Committee unanimously votes in support of emergency use for a booster dose of Moderna’s COVID-19 Vaccine in the U.S

Written by | 27 Oct 2021

Moderna, Inc. confirmed that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose… read more.

Pfizer and BioNTech receive first FDA Emergency Use Authorization of a COVID-19 vaccine booster

Written by | 20 Oct 2021

Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age… read more.

FDA accepts REGEN-COV for priority review for treatment and prophylaxis of COVID-19 – Regeneron Pharma

Written by | 17 Oct 2021

Regeneron Pharmaceuticals, Inc. has announced that the FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized… read more.

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