The FDA stated that the adequacy of the safety database will be a matter of review at the time of BLA submission. The planned BLA submission is targeted for June 2026.
) Larimar Therapeutics Announces FDABreakthroughTherapy Designation for Nomlabofusp in FA and Reiterates Planned BLASubmission in June 2026 ... • Topline open label study data to support BLA submission expected in Q2 2026.
According to the BLA’s claims, the soldiers were seized during what the group refers to as “Operation Herof 2.0”, a continuation of its insurgent campaign in Balochistan....
The Baloch Liberation Army (BLA) reportedly released a video purportedly showing Pakistani... The individuals, identified by the BLA as detained servicemen, are heard appealing to Pakistani authorities.
SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced the FDA has filed for review the BLA for MOLBREEVI as a therapy to treat patients with autoimmune PAP.
"We are proud to be the first to submit a BLA for an abatacept biosimilar which marks a significant milestone in our mission to increase patient access to critical, high-quality biologic therapies," said Milan Kalawadia, CEO, North America, at Dr.
HNSA), today announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S ... The BLA submission for imlifidase is supported by the previously communicated highly statistically significant outcome of the pivotal U.S.
) Hansa Biopharma's Biologics License Application (BLA) for imlifidase accepted by the FDA... HNSA), today announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S.