Regulatory Affairs News Channel

FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

Today, the U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

FDA approves new type of therapy to treat advanced urothelial cancer

The U.S. Food and Drug Administration granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells - in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers.

FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation

The U.S. Food and Drug Administration today granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping. It is estimated that about 8 percent of patients with DMD have this mutation.

FDA launches app for health care professionals

The U.S. Food and Drug Administration announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device.

FDA approves first generics of Gilenya

The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body.

FDA approves novel treatment to target abnormality in sickle cell disease

Today, the U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.

"Today's approval provides additional hope to the 100,000 people in the U.S., and the more than 20 million globally, who live with this debilitating blood disorder," said Acting FDA Commissioner Adm. Brett P. Giroir, M.D.

FDA approves first treatment for inherited rare disease

Today, the U.S. Food and Drug Administration granted approval to Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme (which helps bind oxygen in the blood).

Regulatory Affairs News

FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

FDA approves new type of therapy to treat advanced urothelial cancer

FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation

FDA launches app for health care professionals

FDA approves first generics of Gilenya

FDA approves novel treatment to target abnormality in sickle cell disease

FDA approves first treatment for inherited rare disease

More Pharma News ...

Business & Industry

Research & Development

Conferences & Events

Regulatory Affairs