European Pharmaceutical Review

OCTOBER 17, 2024

In August 2024, the European Commission approved EURneffy (adrenaline nasal spray) in the EU as the first needle-free emergency option to treat anaphylaxis. This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). What are the main advantages of EURneffy over similar treatments?

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

European Pharmaceutical Review

DECEMBER 22, 2023

It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024.

Food and Drug Administration 98

Food and Drug Administration Side effects Safety Food 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. US sales of Stelara totalled $6.4 billion in 2022, according to J&J’s financial results.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Safety 98

European Pharmaceutical Review

OCTOBER 24, 2024

The biologic treatment was granted approval as Kisunla (donanemab-azbt) in the US by the Food and Drug Administration (FDA) in July 2024. In August 2024, Eisai/Biogen’s anti-Aβ mAb Leqembi (lecanemab) became the first [disease-modifying therapy] to be approved for [Alzheimer’s] in the UK”. billion and $2.0

Food and Drug Administration 52

Food and Drug Administration Side effects Medicine Patients 52

Pharmaceutical Technology

APRIL 21, 2023

It will pay another $10m in instalments through to September 2024. Entadfi, a combination of finasteride and tadalafil, is administered as an oral, once-a-day drug to provide a safe and effective treatment option for benign prostatic hyperplasia (BPH), often referred to as enlarged prostate, in men.

Food and Drug Administration 52

Food and Drug Administration Side effects Distribution Sales 52

Pharmaceutical Technology

JUNE 16, 2023

While the drug is marketed in other countries, it is not registered in the US. But while available adjunctive options work well, they come at the cost of safety, said Buntinx, and ANT01 could offer these benefits without additional side effects.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

European Pharmaceutical Review

JULY 18, 2024

What are antibody-drug conjugates and why do they hold potential over other treatment modalities? Antibody drug conjugates (ADCs) are an emerging technology adding significant value to the oncology treatment landscape. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. References Fu et al.

Food and Drug Administration 59

Food and Drug Administration Engineering Pharmacology Side effects 59