STAT

AUGUST 22, 2023

The Food and Drug Administration approved a Pfizer vaccine that aims to protect newborns against RSV by vaccinating pregnant people, STAT tells us. The vaccine, marketed as Abrysvo, previously won approval for adults over the age of 60. Continue to STAT+ to read the full story…

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pharmaphorum

SEPTEMBER 8, 2022

On the strength of phase 2 data, the FDA has awarded coveted breakthrough status to Pfizer’s vaccine against Group B Streptococcus (GBS), given to expectant mothers to prevent invasive infections in newborns and young infants. The post FDA gives Pfizer’s Group B strep vaccine breakthrough status appeared first on.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

It will expire on 24 November 2026, and the paediatric exclusivity lasts until 24 May 2027. Viatris is seeking approval from the US Food and Drug Administration (FDA) to market Januvia and Janumet’s generic versions in the country. Merck has also permitted the sale of generic versions of Janumet XR to the market in July 2026 or before.

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pharmaphorum

SEPTEMBER 30, 2022

Viatris is seeking FDA approval to market generic versions of both Januvia and Janumet in the US. That challenged the ‘708 patent – which expires in November 2026 – as well as one other (No. Viatris appealed that decision to the Court of Appeals for the Federal Circuit, which has now upheld the earlier decision.

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pharmaphorum

FEBRUARY 7, 2022

Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US. It also abandoned an mRNA-based vaccine for COVID-19 and suffered delays to another COVID-19 shot partnered with GlaxoSmithKline.

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PharmaShots

FEBRUARY 21, 2023

threshold by 2026. In Aug’21, the US FDA cleared QSam’s IND application for CycloSam. In Jun’21, the company initiated the evaluation of FAP-2286 in a P-I/II clinical trial (LuMIERE) following the US FDA’s IND clearance. In Sep’21, the US FDA granted DUNP19 an ODD for Osteosarcoma.

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The FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. covered insulin product or vaccine). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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