Complete response letter
Aldeyra faces FDA rejection risk for dry eye drug due to review issues
Aldeyra Therapeutics confronts a daunting situation as regulatory concerns cast doubt on the future of its dry eye disease medication, ...
Alnylam gives up on Onpattroâs US expansion after FDA rejects its rare heart disease indication
Despite receiving an endorsement from an advisory committee, the FDA has reached a different conclusion regarding the benefit-risk profile of ...
FDA Flags Issues in Galderma’s Botulinum Toxin Filing
While Galderma seeks to expand its range of injectable aesthetic treatments by gaining FDA approval for addressing crow’s feet and ...
Eli Lilly Faces Third FDA Rejection in 2023, Eczema Drug Lebrikizumab Denied Approval
Eli Lilly, which had set ambitious plans to introduce four new drugs in 2023, has faced another setback on the ...
ImmunityBio cuts 50 jobs in California and Florida after FDA snubs its bladder cancer drug
Following an FDA rejection earlier this year, ImmunityBio has initiated its second round of layoffs in less than a year, ...
UCB’s psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay
After facing delays related to manufacturing issues, UCB’s psoriasis medication, bimekizumab, is awaiting the next steps in its FDA review ...
Astrazeneca Suffers Setback As FDA Rejects Ultomiris For Rare Autoimmune Disease
AstraZeneca’s plans to expand the use of Ultomiris in the United States have encountered a setback, as the FDA issued ...
Outlookâs eye drug Lytenava fails to win FDA approval, despite positive trial
Outlook Therapeutics has been working on a reformulated version of Rocheâs cancer drug Avastin for the treatment of certain eye ...
Akebia plans to resubmit vadadustat to FDA after rejection
After facing significant setbacks, including disappointment, a partnership setback, and an FDA dispute, Akebia Therapeutics has regrouped and is poised ...
Phathom Pharmaceuticals Boosts Erosive GERD Application with Six-Month Stability Data Submission for Vonoprazan
Phathom Pharmaceuticals, a pioneering biopharmaceutical company dedicated to groundbreaking solutions for gastrointestinal ailments, has announced a significant stride in its ...
FDA Denies Approval for Galeraâs Oral Mucositis Drug
The FDA has issued a complete response letter in response to the new drug application (NDA) for avasopasem manganese (GC4419), ...
FDA rejects Citius’ resurrected IL-2 lymphoma treatment
Source – Citius Pharmaceuticals The FDA has declined Citius Pharmaceuticals’ request to market Lymphir, an updated version of a lymphoma ...
FDA rejects Amneal’s Parkinson’s drug, $500M peak sales goal unattainable
Source – Amneal Pharmaceuticals On July 3, 2023, Amneal Pharmaceuticals’ plans to launch its extended-release Parkinson’s disease treatment, IPX203, by ...
As a result of production issues, the FDA rejected Eton Pharma’s proposed therapy for methanol poisoning
Source – Eton Pharmaceuticals Eton Pharmaceuticals’ dehydrated alcohol injection did not receive approval from the FDA and instead received a ...
FDA rejects F2G’s innovative antimicrobial
Source – F2G After the FDA declared it was unable to approve its Olorofim candidate, F2G’s quest to break a ...
