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FDA Articles

Savara shares more than doubled on Monday after the firm announced that the FDA has granted Breakthrough Therapy designation for its autoimmune pulmonary alveolar proteinosis treatment Molgradex.
AstraZeneca has announced that the FDA has approved its companion diagnostic test that identifies patients with metastatic pancreatic cancer.
Immunomedics shares made a handy gain on Thursday after the company announced that the FDA has accepted its Biologics License Application for its breast cancer treatment.
Spectrum Pharma shares were halved on Thursday after the firm provided an update on its midstage cancer study some updates on its late-stage programs with the FDA.
The FDA has approved Allergan's treatment for migraines in adults. The drug is the first of its class to obtain FDA approval, but the new drug will compete with other recently released treatments for...
Here, 24/7 Wall St. has included a calendar of a few of the biggest clinical trial and FDA updates to watch for going into 2020.
Intra-Cellular Therapy shares practically doubled on Monday after the firm announced that the FDA has approved Caplyta for the treatment of schizophrenia in adults
NewLink Genetics and Merck shares made handy gains on Friday after it was announced that the FDA has granted approval to Ervebo, the Zaire Ebola virus vaccine V920.
Prevail Therapeutics shares jumped early on Tuesday after the firm announced that the FDA has granted Orphan Drug designation for its dementia treatment.
Sarepta shares jumped on Friday after the firm announced that the FDA has approved Vyondys 53 (golodirsen) for the treatment of Duchenne muscular dystrophy (DMD) in certain patients.
Correvio Pharma shares were crushed after the firm announced the FDA Cardiovascular and Renal Drugs Advisory Committee decision for its New Drug Application seeking approval for Brinavess. This could...
Dermira shares jumped on Tuesday after the firm announced that the FDA has granted Fast Track designation for lebrikizumab, its treatment moderate-to-severe atopic dermatitis.
Aquestive Therapeutics shares jumped early on Monday after the firm announced the completion of its rolling submission of a New Drug Application (NDA) to the FDA for its therapeutic candidate...
Here 24/7 Wall St. includes a calendar of a few of the biggest companies expecting clinical trial and FDA updates in the month of December.
Global Blood Therapeutics shares jumped on Tuesday after the firm announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Oxbryta (voxelotor) tablets for the...