Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). Paxlovid’s most common side effect is diarrhoea.

Food and Drug Administration 59

Food and Drug Administration FDA Side effects Safety 59

Pharmaceutical Technology

APRIL 21, 2023

The company will make a $20m upfront payment, which includes $6m paid at closing and an additional $4m payment in the fiscal year 2023. The US Food and Drug Administration granted approval to Entadfi for the treatment of BPH in December 2021. It will pay another $10m in instalments through to September 2024.

Food and Drug Administration 52

Food and Drug Administration Side effects Distribution Sales 52

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. The CAR T cells need to persist in the blood to expand and elicit maximal effect, and there is a correlation between expansion and persistence and response. Furthermore, point-of-care CAR T-cell manufacturing provides clinical benefits.

Manufacturing 104

Manufacturing Food and Drug Administration Patients Pharma 104

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 98

Food and Drug Administration Patients Leads Side effects 98

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 98

Food and Drug Administration Patients Leads Side effects 98

Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Prospecting 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. 2023; 3 Tsuchikama et al.

Food and Drug Administration 59

Food and Drug Administration Engineering Pharmacology Side effects 59

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. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. billion in 2029, while Calquence is expected to make $5.31

Food and Drug Administration 52

Food and Drug Administration Side effects Sales Food 52

European Pharmaceutical Review

JANUARY 3, 2023

Sensorion, a biotechnology company has announced that the first patient has been enrolled in its NOTOXIS Phase IIa proof of concept clinical trial of SENS-401 (Arazasetron) in cancer patients experiencing cisplatin-induced ototoxicity (permanent hearing loss), a serious side effect of key chemotherapeutic agent cisplatin.

Patients 52

Patients Food and Drug Administration Side effects Food 52

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Marketing 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau. 2023 AD/PD Conference.

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97