Regulatory Affairs News

FDA approves first drug for spinal muscular atrophy

FDAThe U.S. Food and Drug Administration has approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is an injection administered into the fluid surrounding the spinal cord.
Read more ...

FDA grants accelerated approval to new treatment for advanced ovarian cancer

FDAThe U.S. Food and Drug Administration has granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.
Read more ...

FDA research to help speed development of Zika virus vaccines and therapeutics

FDAA new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today in PLoS Pathogens, is the description of a neonatal mouse model that provides a platform for potentially improving and expediting studies to understand the causes and effects (pathology) of the Zika virus.
Read more ...

FDA awards 21 grants to stimulate product development for rare diseases

FDAThe U.S. Food and Drug Administration today announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry with research spanning domestic and international clinical sites.
Read more ...

FDA launches #NaloxoneApp competition to spur innovative technologies to help reduce opioid overdose deaths

FDAThe U.S. Food and Drug Administration has announced the 2016 Naloxone App Competition, a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose. The FDA, with support from the National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA), is inviting computer programmers, public health advocates, clinical researchers, entrepreneurs and innovators from all disciplines to
Read more ...

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

FDAThe U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD.
Read more ...

FDA updates warnings for fluoroquinolone antibiotics

FDAThe U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.
Read more ...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]