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FDA Approves Inrebic (fedratinib) for the Treatment of Patients With Myelofibrosis drugs
August 19, 2019
Celgene Corporation announced the U.S. Food and Drug Administration (FDA) has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or ...
FDA Approves Rinvoq (upadacitinib), an Oral JAK Inhibitor for the Treatment of Moderate to Severe Rheumatoid Arthritis drugs
August 19, 2019
AbbVie, a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor...
Roche's first FDA-approved tumour-agnostic medicine worldpharmanews
August 19, 2019
Roche announced that the US Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).
Emcure knocked by the FDA for sterility issues after injectable drug recall fiercepharma
August 18, 2019
Emcure Pharmaceuticals has had its share of run-ins with the FDA in the past over the sterility of one of its Indian manufacturing plants. Now, it can notch one more black mark on its belt.
Dr. Reddy's Copaxone, NuvaRing generics derailed by FDA fiercepharma
August 18, 2019
Dr. Reddy’s, which has been dealing with repeated manufacturing setbacks from the FDA, is now facing a new regulatory challenge.
EmphyCorp FDA Submission for Rx New Non-Steroidal Nasal Spray for Pulmonary Fibrosis americanpharmaceuticalreview
August 16, 2019
mphyCorp announced the completion of a clinical trial to define medical endpoints as requested by the FDA for the NDA marketing application in patients with Pulmonary Fibrosis, under its Orphan Drug Designations for ...
Harmony Biosciences Announces FDA Approval of WAKIX americanpharmaceuticalreview
August 16, 2019
Harmony Biosciences announced the U.S. Food and Drug Administration (FDA) approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.
FDA Proposes Graphic Warning Labels on Cigarettes drugs
August 16, 2019
Smokers would have to get past some gruesome imagery to purchase a pack of cigarettes under a new rule proposed Thursday by the U.S. Food and Drug Administration.
FDA Approves Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors drugs
August 16, 2019
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive...
FDA Approves Wakix (pitolisant), a First-in-Class Medication for the Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy drugs
August 16, 2019
Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) approved Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

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