FDA
Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.
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Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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The FDA issued Provention a CRL that focuses on a single low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in health volunteers.
FDA greenlit Jazz Rylaze for use as a component of a chemotherapy regimen for the treatment of ALL or lymphoblastic lymphoma in pediatric and adult patients.
Life sciences news sometimes flies under the radar. So here’s a look at a few stories you may have missed.
If approved, lenacapavir would be offered to HIV patients who have been heavily treated for the disease and have multi-drug-resistant HIV.
The U.S. FDA granted Fast Track Designation to three biopharma companies for the treatment of LGMD, episodic bleeding and leukemia.
Roche had a big week, scoring wins but also stepping away from its gene therapy partnership with 4D Molecular Therapeutics.
The U.S. FDA has had a mix of announcements this week, from drug approvals to the acceptance of NDAs and INDs. Here’s a look.
By merging with New Haven’s SPAC Thimble Point Acquisition Corp., Pear will be valued at $1.6 billion.
Incyte had a particularly big week scheduled with the U.S. FDA, which included two PDUFA dates and an advisory committee meeting. In addition, Ascendis had a target action date.
The FDA said that arimoclomol, which has been studied and submitted for NPC indication, needs further data to support its use in this rare, progressive genetic disorder.