FDA
Avadel and Jazz Pharma, a leader in treating sleep disorders, are locked in a patent dispute. If it receives final FDA approval, Avadel’s Lumryz could challenge Jazz’s market dominance.
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Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
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The expanded approval was made based on positive data from a second interim analysis of the Phase II KEYNOTE-629 trial.
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.