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Vanda Pharmaceuticals Receives CRL from FDA for HETLIOZ® in the Treatment of Jet Lag Disorder americanpharmaceuticalreview
August 20, 2019
Vanda Pharmaceuticals Inc. announced that on August 16 2019, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for ...
RINVOQ™ arthritis treatment granted approval by FDA europeanpharmaceuticalreview
August 20, 2019
The FDA has given its approval to RINVOQ for the treatment of active rheumatoid arthritis after the drug reached its endpoints in clinical trials.
New Antibiotic Xenleta Approved for Community-Acquired Bacterial Pneumonia drugs
August 20, 2019
Xenleta (lefamulin) has been approved to treat adults with community-acquired bacterial pneumonia, the U.S. Food and Drug Administration announced .
FDA Approves AbbVie's New RA Drug contractpharma
August 20, 2019
Approximately 30 percent of patients treated with RINVOQ achieved clinical remission at week 12 and week 14.
Genentech gets FDA approval for tumour-agnostic drug Rozlytrek pharmaceutical-technology
August 19, 2019
The US Food and Drug Administration (FDA) has approved Roche division Genentech’s tumour-agnostic drug Rozlytrek, which targets a specific genetic defect called neurotrophic tyrosine receptor kinase (NTRK).
FDA approves first non-controlled substance narcolepsy drug pharmaceutical-technology
August 19, 2019
Harmony Biosciences has announced the US Food and Drug Administration (FDA) has approved Wakix (pitolisant) to treat excessive daytime sleepiness (EDS) in adults with narcolepsy.
Complete response letter sent for two generic products europeanpharmaceuticalreview
August 19, 2019
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
Vaping Industry Group Sues to Delay FDA Review of E-Cigarettes drugs
August 19, 2019
A vaping industry group has launched legal action to delay the U.S. Food and Drug Administration's upcoming review of electronic cigarettes.
FDA Grants Accelerated Approval to Rozlytrek americanpharmaceuticalreview
August 19, 2019
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect ...
FDA Approves Inrebic Capsules for Myelofibrosis drugs
August 19, 2019
Inrebic (fedratinib) capsules have been approved to treat adults with intermediate-2 or high-risk primary or secondary myelofibrosis, making it the second drug approved to treat patients with this disease...

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