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Doravirine

[L4562] Doravirine is formally indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, further expanding the possibility and choice of therapeutic

Calcium carbonate

Calcium carbonate is an inorganic salt used as an antacid. It is a basic compound that acts by neutralizing hydrochloric acid in gastric secretions. Subsequent increases in pH may inhibit the action of pepsin. An increase in bicarbonate ...

Tezepelumab

[L39504] Tezepelumab was also approved by the European Commission on September 19, 2022.[L44712]

Myrcludex B

Myrcludex B is under investigation in clinical trial NCT03546621 (A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination

Apalutamide

In a phase-2 multicenter open-label study, 89% of patients with non-metastatic, castration-resistant prostate cancer had ≥50% PSA decline at week 12 of apalutamide treatment [A31846]. … Approximately 10 to 20 % of prostate cancer cases are castration-resistant, and up to 16% of these patients show no evidence of cancer metastasis at the time of castration-resistant diagnosis [L1295].

Valbenazine

This approval was supported by positive results in multiple trials, including the KINECT-HD Phase 3 study and the ongoing KINECT-HD2 open-label extension trial.

Pirfenidone

Pirfenidone is a synthetic pyridone drug. It is an antifibrotic agent with anti-inflammatory and antioxidant properties that is used to treat idiopathic pulmonary fibrosis (IPF), which is a chronic, progressive form of interstitial pneum...

CX516

Fidanacogene elaparvovec

[L49469] This approval was based on positive results demonstrated in the open-label, single-arm Phase 3 BENEGENE-2 study, where the annualized bleeding rate (ABR) was observed to be 1.3 for the 12 months

Tibolone

It has been used in Europe for almost 2 decades, primarily for the prevention of postmenopausal osteoporosis and the treatment of post-menopausal symptoms [L1720]. … Tibolone (Livial, Org OD 14), produced by Organon (West Orange, NJ), is a synthetic steroid that possesses estrogenic, androgenic and progestogenic properties.