RDR Alert®

The FDA is allowing Rocket Pharmaceuticals to conduct a global phase I study testing a new treatment approach for Pyruvate Kinase Deficiency.

The newly approved drug is a combination of 3 drugs that target the most common cystic fibrosis mutation.

The indication expands the therapy to include newly diagnosed and persistent adults ITP patients who have had an insufficient response to therapy.

The US Food and Drug Administration has approved minocycline topical foam, 4% for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgarism in adults and pediatrics patients 9 years of age or older.

Investigative drug DB102 will be assessed in approximately 200 patients with newly diagnosed glioblastoma in a Denovo-led phase 2b trial.

The new implanted drug will help treat adults suffering from erythropoietic protoporphyria with a history of photoxic reactions.

Gail Rodich, MD, discusses what the approval of rituximab, which has approvals for 9 other conditions including rheumatoid arthritis, means for pediatric patients with GPA and MPA.

The approval is based on findings showing patients on the drug plus VTd had a 53% reduction in risk of disease progression or death, compared to lone VTd.

The approval for interstitial lung disease associated with systemic sclerosis or scleroderma makes nintedanib the first therapy for the rare condition.

The once-daily capsule therapy is the first drug indicated for the rare disease since ruxolitinib in 2011.

The investigative monoclonal antibody from Regeneron shows significant benefit for patients with the rare, severe homozygous familial hypercholesterolemia.

The FDA has been informed by the therapy's manufacturer that data was manipulated during its animal testing phase.

AbbVie's submitted NDA for elagolix for the treatment of heavy menstrual bleeding associated with uterine fibroids in women is supported by the results of 2 phase 3 studies.

The therapy, which carries a Boxed Warning for liver injury risks, is indicated for patients who do not benefit from surgery.

Investigators find improved liver function in hepatocellular carcinoma patients tied to aspirin use in a new retrospective review.

FDA announces 137 new drug approvals in 2018 represents an 11% increase over 2017.

Merck announced the FDA's approval of their NDA for imipenem, cilastatin, and relebactam (Recarbrio) on Wednesday morning.

Former Vice President Joe Biden's presidential campaign has resulted in the nonprofit organization's indefinite suspension.

The FDA announced the approval of the nuclear export inhibitor based on the results of the STORM study and the ongoing BOSTON study.

The CD38 monoclonal antibody has been approved in combination with lenalidomide and dexamethasone to treat patients ineligible for autologous stem cell transplant.

FDA approval of eculizumab (Soliris) marks the first approval for the treatment of NMOSD.

Last year, the FDA approved the drug as a novel therapy for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled for medical or dental procedure.

Acer Therapeutics Inc. announced on Tuesday they received a CRL from the FDA regarding their NDA from celiprolol (Edsivo).

How advanced biologic care and symptom management programs fail patients more advanced in their disease.

The first-approved therapy for what clinicians once called the 'chronic' form of multiple sclerosis has changed standards of care.