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CHMP recommends Velsipity (etrasimod) for the treatment of ulcerative colitis – Pfizer

Written by | 21 Dec 2023

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.

CHMP positive for Talzenna + Xtandi (talazoparib + enzalutamide) to treatmetastatic castration-resistant prostate cancer – Pfizer

Written by | 17 Nov 2023

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Talzenna…. read more.

FDA approves Bosulif (bosutinib) for pediatric Ph+ CP-CML – Pfizer

Written by | 8 Oct 2023

The FDA has approved bosutinib (Bosulif) for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome (Ph)–positive, chronic-phase chronic myelogenous leukemia (CP-CML) that… read more.

European Commission approves Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata – Pfizer

Written by | 29 Sep 2023

Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe… read more.

EU approves Abrysvo for respiratory syncytial virus – Pfizer

Written by | 3 Sep 2023

Pfizer announced that the European Commission (EC) has granted marketing authorization for Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both… read more.

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.

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