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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.

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.

EU approves Ngenla in growth hormone deficient children – Pfizer + OPKO Health

Written by | 9 Mar 2022

Pfizer and OPKO Health announced that the European Commission has granted marketing authorization for the next-generation long-acting recombinant human growth hormone Ngenla (somatrogon), a once-weekly injection to treat… read more.

Antibodies improve in quality for months after COVID-19 vaccination

Written by | 18 Feb 2022

For at least six months after COVID-19 vaccination, antibodies produced by immune cells become steadily more formidable and more precisely targeted against the virus that causes COVID-19, according… 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.

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.

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.

UK MHRA grants marketing authorisation for Cibinqo for adults and adolescents with moderate to severe atopic dermatitis – Pfizer

Written by | 22 Sep 2021

Pfizer Inc. announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1… read more.

The Bristol-Myers Squibb-Pfizer Alliance welcomes the decision by the U.S. Court of Appeals for the Federal Circuit upholding the Eliquis Patents

Written by | 11 Sep 2021

The Bristol-Myers Squibb-Pfizer Alliance issued the following statement: We welcome the decision by the Court of Appeals for the Federal Circuit’s to affirm the U.S. District Court’s August… read more.

FDA approves Ticovac for tick-borne encephalitis – Pfizer

Written by | 2 Sep 2021

Pfizer Inc. announced that the FDA has approved Ticovac (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. Ticovac… read more.

Pfizer and BioNTech announce submission of initial data to FDA to support booster dose of COVID-19 Vaccine

Written by | 31 Aug 2021

Pfizer Inc. and BioNTech SE announced that they have submitted Phase 1 data to the FDA to support the evaluation of a third, or booster, dose of the… 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.

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