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Home » complete response letters

Articles Tagged with ''complete response letters''

Thyroid anatomy

CRL offers clarity for Ascendis’ Transcon PTH, as EMA decision remains on track

May 1, 2023
By Jennifer Boggs
It’s not often that getting an NDA rejected by the U.S. FDA is cause for a company’s stock to rise. But in the case of Ascendis Pharma A/S, the agency’s anticipated complete response letter (CRL) for Transcon PTH (palopegteriparatide) offered some much-needed clarity and a potentially optimistic time frame for an NDA resubmission seeking approval of the once-daily hormone replacement therapy for hypoparathyroidism, news that sent the company’s shares (NASDAQ:ASND) up 24%, or $16.78, to close May 1 at $86.74.
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Technegas illustration

US FDA resets review clock for Cyclopharm’s Technegas for pulmonary embolism

April 25, 2023
By Tamra Sami
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29.
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Technegas illustration

US FDA resets review clock for Cyclopharm’s Technegas for pulmonary embolism

April 25, 2023
By Tamra Sami
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29.
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Technegas illustration

US FDA resets review clock for Cyclopharm’s Technegas for pulmonary embolism

April 24, 2023
By Tamra Sami
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29.
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FDA accepts Mesoblast’s BLA resubmission for remestemcel-L in pediatric GVHD

March 14, 2023
By Tamra Sami
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
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FDA accepts Mesoblast’s BLA resubmission for remestemcel-L in pediatric GVHD

March 9, 2023
By Tamra Sami
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
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FDA cites weak efficacy as it hands Cytokinetics CRL for heart failure drug

March 1, 2023
By Caroline Richards
The U.S. FDA issued Cytokinetics Inc. a complete response letter (CRL) for omecamtiv mecarbil, branding the clinical evidence behind it as not “persuasive” enough to establish its effectiveness for reducing the risk of heart failure events and cardiovascular death. The company is developing the drug as an add-on therapy for patients with worsening heart failure who remain at high risk for heart failure events and hospitalization.
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Nexobrid

Mediwound fends off a CRL and COVID for FDA’s burn treatment approval

Dec. 30, 2022
By Lee Landenberger
After working through a complete response letter (CRL) brought about by COVID-19 from the U.S. FDA in June 2021, Mediwound Ltd. has received the agency’s approval for Nexobrid (anacaulase-bcdb) to treat severe burns in adults.
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Real fluorescence microscopic view of human neuroblastoma cells

After a brutal adcom, Y-mabs gets an anticipated CRL

Dec. 5, 2022
By Lee Landenberger
Following the tone set in an October U.S. FDA Oncologic Drugs Advisory Committee meeting, the agency has issued a complete response letter (CRL) to Y-mabs Therapeutics Inc.’s BLA for Omblastys (131I-omburtamab) to treat central nervous system/leptomeningeal metastasis arising from neuroblastoma.
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US still awaiting first HDV drug after FDA hits Gilead’s Hepcludex with CRL

Oct. 28, 2022
By Jennifer Boggs and Michael Fitzhugh
The U.S. FDA declined to approve Gilead Sciences Inc.’s Hepcludex (bulevirtide), issuing a complete response letter (CRL) citing manufacturing and delivery concerns for the antiviral aimed at treating confirmed chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. Acquired in Gilead’s 2021 buyout of Myr GmbH, Hepcludex received conditional approval from the European Commission in 2020 and would have been the first drug cleared for HDV in the U.S. Its delay, however, could give a boost to Eiger Biopharmaceuticals Inc., which is expected to report phase III data for lonafarnib by the end of 2022.
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