PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known side effect of Wezlana is infection. Sustainable biosimilar competition in Europe: can it be achieved?

Food and Drug Administration 87

Food and Drug Administration FDA Side effects Safety 87

Pharmaceutical Technology

APRIL 24, 2023

The combination therapy also caused fewer side effects, with heart problems and hypertension as the most common ones, based on the final draft guidance. While Imbruvica maintained a previously strong position on the market, competition has chipped away at the inhibitor’s market share. billion in the same year.

Food and Drug Administration 52

Food and Drug Administration Side effects Sales Food 52

Pharma Marketing Network

MARCH 25, 2023

Pharmaceutical advertising is a crucial aspect of promoting and marketing drugs to the public. With the increase in competition, it has become essential for pharmaceutical companies to find the most effective methods of advertisement to reach their target audience. “Direct-to-Consumer Advertising of Prescription Drugs.”

Pharma 52

Pharma Food and Drug Administration Prescription Pharmaceutical 52

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

Prescription 52

Prescription FDA Food and Drug Administration Medical 52

Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Subjects were dosed over seven days, and reportedly only experienced mild to moderate side effects with no withdrawals. coli a frequent cause of bloodstream infections that carries a 15-20% fatality rate.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects FDA 98