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US FDA approves KalVista Pharma's swelling disorder drug, shares rise
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral ...
STAT4m
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
ALS Community Files Citizens’ Petition asking FDA to Approve NurOwn Stem Cell Therapy
New and Unprecedented Survival, Respiratory, and Biomarker Data Prove that NurOwn Helps People with ALS Live Longer and Live ...
pharmaphorum1h
KalVista bags FDA approval for delayed oral HAE drug
KalVista Pharma has finally received FDA approval for its oral kallikrein inhibitor sebetralstat, becoming the first ...
ALS News Today1h
FDA grants orphan drug status to ALS gene therapy SNUG01
The FDA granted orphan drug designation to Sineugene Therapeutics' SNUG01, a first-in-class experimental gene therapy for ...
Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-101 (IL13Ra2-targeted CAR T-cells) to Treat Astrocytomas and Glioblastoma
In an ongoing Phase 1 trial published in Nature Medicine, MB-101 was well-tolerated and 50% of patients achieved stable ...
Agence France-Presse6m
CorFlow Therapeutics Announces FDA Approval of the MOCA-II IDE Pivotal Trial to Validate a Novel Heart Attack Care Technology
EU chief, Trump had 'good exchange' by phone Sunday CorFlow Therapeutics AG (CorFlow), a pioneering company in the field of cardiac care targeting microvascular disease, today announced that the U.S.
RFK Jr.'s FDA officials overrode career staff to limit COVID shots
The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.
PMLive1h
Regeneron’s Lynozyfic granted FDA accelerated approval to treat multiple myeloma
Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) has been granted accelerated approval by the US Food and Drug ...
FDA Issues Most-Serious Risk Warning for Cucumber Recall
Consumption of impacted products could cause "serious adverse health consequences or death," according to the FDA.
US FDA approves KalVista Pharma's swelling disorder drug
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug for a type of hereditary ...