Tag Archive for: FDA approval

Like its branded reference product, Selarsdi is a subcutaneous injection that can be used to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis in pediatric and adult patients. Unlike Stelara, however, Selarsdi is not approved for Crohn’s disease and ulcerative colitis.

AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.

Orchard Therapeutics secured the FDA’s first approval for an autologous gene therapy to treat the rare metabolic disease metachromatic leukodystrophy in children.

The product is the first FDA-approved ophthalmic clobetasol propionate drug to hit the market, and is the first steroid to enter the ophthalmic space in more than 15 years, according to yesterday’s announcement.

Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene.

With the potential FDA approval of an MDMA-based therapy for PTSD on the horizon, biopharma stakeholders are eyeing psychedelics with fresh anticipation.

The company touts Penbraya as the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.

The label for the achondroplasia drug, which promotes endochondral bone growth, now covers children under five years of age with the rare genetic disease causing the most common form of dwarfism.

Following a delay and an initial rejection, UCB’s IL-17A/IL-17F blocker bimekizumab was approved for moderate-to-severe plaque psoriasis, which will now be marketed with the brand name Bimzelx.

The drug, Zilbrysq is the first once-daily subcutaneous targeted C5 complement inhibitor approved for generalized myasthenia gravis (gMG) and is currently the only self-administered targeting option rare autoimmune disease.