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FDA grants priority review for Xtandi in non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence – Astellas + Pfizer

Written by | 1 Sep 2023

Pfizer Inc. and Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the companies’ supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for… read more.

Elrexfio receives FDA accelerated approval for relapsed or refractory multiple myeloma – Pfizer

Written by | 19 Aug 2023

Pfizer Inc. announced the FDA has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received… read more.

CHMP recommends Abrysvo the first RSV vaccine to protect infants up to 6 months of age and older adults – Pfizer

Written by | 31 Jul 2023

The CHMP has recommended granting a marketing authorization for Pfizer’s Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is… read more.

CHMP recommends Litfulo, an oral treatment for alopecia areata – Pfizer

Written by | 27 Jul 2023

Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Litfulo (ritlecitinib), an oral… read more.

Paxlovid associated with lower risk of hospital admission

Written by | 19 Mar 2023

A Kaiser Permanente study confirms the benefit of nirmatrelvir-ritonavir, also known as Paxlovid, as an early-stage treatment to prevent hospitalization for people with mild to moderate COVID-19, regardless… read more.

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.

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