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Roche haemophilia drug gets fast FDA review in expanded use pharmaphorum
April 18, 2018
The FDA has granted ‘Breakthrough Therapy’ status for Roche’s Hemlibra (emicizumab) for people with haemophilia A without factor VIII inhibitors, as the Swiss firm aims to take market share from rivals including Shire.
FDA Allows the First Use of Tracer-QC at Massachusetts General Hospital biospace
April 18, 2018
Trace-Ability, Inc., announced today that the FDA has allowed the first use of its product, Tracer-QC, for release testing of an imaging agent used in Positron Emission Tomography (PET) - [N-13]Ammonia for injection.
FDA Provides Full Approval to Praxbind, Specific Reversal Agent for Pradaxa biospace
April 18, 2018
Boehringer Ingelheim Pharmaceuticals, Inc.today announced that the U.S. Food and Drug Administration (FDA) has provided full approval for Praxbind®, the specific reversal agent for Pradaxa® (dabigatran etexilate mesylate).
FDA Grants Genentech’s Hemophilia Drug Breakthrough Therapy Designation Despite Reports of Patient Deaths biospace
April 18, 2018
The U.S. Food and Drug Administration (FDA) granted Genentech, a Roche company, Breakthrough Therapy Designation for Hemlibra (emicizumab-kxwh) for hemophilia A without factor VIII inhibitors.
MediMergent and FDA Launch New Stakeholder Initiative against Medication Non-Adherence/Persistence Crisis biospace
April 17, 2018
Healthcare data collection and analytics company MediMergent, LLC and the Center for Drug Evaluation and Research of the FDA recently convened an Advisory Board to address strategies to combat the public health crisis related to medication non-adherence
Eagle Pharmaceuticals’ Vasopressin ANDA Accepted for Filing by the FDA biospace
April 17, 2018
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or “the Company”) today announced that it has submitted and the U.S. Food and Drug Administration (FDA) has accepted for filing its abbreviated new drug application (ANDA) for vasopressin injection, 1ml.
Roche receives FDA clearance for cobas® CT/NG for cobas® 6800/8800 Systems biospace
April 17, 2018
Roche announced today that FDA has provided 510(k) clearance for cobas® CT/NG for use on the cobas® 6800/8800 Systems for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic indivi
Alkermes Gains NDA Acceptance for MDD Treatment That was Previously Rejected by the FDA biospace
April 17, 2018
In a stunning about-face the U.S. Food and Drug Administration (FDA) has accepted Alkermes New Drug Application (NDA) for ALKS 5461, a treatment for major depressive disorder, the company announced this morning. The FDA rejected the NDA at the end of Marc
Roche Diagnostics Assay Receives FDA Clearance for STD Testing biospace
April 17, 2018
Roche said it has gained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for cobas CT/NG for use on the cobas 6800/8800 Systems for the detection of chlamydia and gonorrhea in both symptomatic and asymptomatic patients.
FDA Provides New Guidance for Next-Generation Sequencing Test biospace
April 16, 2018
The U.S. Food and Drug Administration (FDA) finalized two separate guidances for next-generation sequencing technologies.

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