The FDA has granted approval to EMD Serono for Gonal-f RFF Redi-ject (follitropin alfa injection), a disposable pre-filled drug injector...
Merck KGaA has announced that the company received FDA approval for a new version of GONAL-f (follitropin alfa injection) prefilled pen.
In adult women • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate. • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer. • GONAL-f in association with a luteinising hormone (LH) preparation is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. In adult men • GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
The Committee for Human Medicinal Products (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive...
A Phase II clinical trial for F 627,recombinant G-CSF from Generon(Shanghai)Corporation, has been started after FDA regulatory clearance. The study...
Lantheus Medical Imaging has announced that results from its first Phase III study of flurpiridaz F 18 for myocardial perfusion...