Drug Pipeline News

Currently, golimumab is approved in adults with moderately to severely active ulcerative colitis.

The federal agency has set a target action date of June 10, 2025 for potential approval.

Arcutis seeks FDA approval for roflumilast cream 0.05% (ZORVYE) to treat mild to moderate atopic dermatitis in children 2 to 5 years.

The FDA has approved Crenessity for managing classic CAH in patients 4 years and up, reducing steroid doses while controlling hormones, offering a safer treatment option.

The halt follows a severe respiratory disease safety signal observed in a July 2024 phase 1 trial of Moderna's mRNA-1345 and mRNA-1365 vaccine candidates.

Pharming Group N.V. plans to include these findings in worldwide regulatory filings in 2025.

The submission to treat PsO is for children aged 6 years and up while the jPsA submission is to treat children aged 5 years and older.

Both monthly migraine days and headache days were reduced vs placebo in patients aged 6 to 17 years.

101-PGC-005 is Type IA prodrug of dexamethasone that targets CD206+ macrophages.

If approved, SL1009 has the potential to be the first approved medication for PDCD, and would be available as an oral solution.

Currently, there are no treatments for the serious, rare pediatric disease.

Once-daily icotrokinra versus placebo demonstrated clinically significant skin clearance in those with moderate-to-severe plaque psoriasis.

Results demonstrated that daily oral infigratinib treatment led to increases in annualized height velocity and improvement in body proportionality.

With this expanded FDA clearance, the wearable becomes the first FDA-cleared, non-drug therapy to treat acute migraines in children.

The application indication is for adults and pediatric patients aged 12 years and older with CSU whose disease is not adequately controlled with H1 antihistamines.

With the decision, Kebilidi becomes the first FDA-approved gene therapy for AADC deficiency, and is indicated for adult and pediatric patients.

A target action date for potential approval of prademagene zamikeracel (pz-cel) has been set for April 29, 2025.

Data stems from the first 4 patients dosed in a low-dose cohort of an ongoing phase 1/2 open-label trial.

The initiation of a phase 2 study of the investigational 31-valent pneumococcal conjugate vaccine is expected by the end of January 2025.

The federal agency has not raised any concerns regarding safety and efficacy of tapinarof cream, 1%.

Application acceptance was based on positive results with monthly and bi-monthly dosing data from a phase 3 trial.

The approval makes methotrexate, currently, the only only oral liquid methotrexate on the market approved for both adult and pediatric indications.

The fibrin sealant solution is now available in 18 countries.

Look back at several quick video interviews discussing the expanding role of artificial intelligence, how RSV treatment has evolved, and much more.

The TrustTSC trial did not achieve its primary endpoint of percent reduction in 28-day frequency of TSC-associated seizures.

Interim analysis of the phase 3 REGAL Trial is anticipated in this quarter of 2024.

There were no treatment or RSV-related deaths during the study.

The approved indication is for patients aged 7 years and up with narcolepsy to treat cataplexy or excessive daytime sleepiness.

Approval is based on a study in 116 adult and pediatric male patients with either severe hemophilia A or severe hemophilia B, both without inhibitors.

This decision marks the second time the FDA has issued a complete response letter (CRL) for dasiglucagon to treat hypoglycemia in patients 7 days and up with congenital hyperinsulinism.