Eli Lilly and Company announced baseline results from the GERAS-US Study examining the societal costs associated with mild cognitive impairment (MCI), mild dementia (MILD), and caring for someone… read more.
Adamis Pharmaceuticals Corporation announced the resubmission of the Company’s New Drug Application (“NDA”) to the FDA for its Zimhi (naloxone HCI Injection, USP) 5mg/0.5mL product candidate for the… read more.
Bone Therapeutics announces it has commenced treating the first patients for the pivotal JTA 004 phase III clinical study in Hong Kong SAR. Several clinical trial sites in… read more.
Bone Therapeutics announces it has commenced treating the first patients for the pivotal JTA 004 phase III clinical study in Hong Kong SAR. Several clinical trial sites in… read more.
Blueprint Medicines announced that the FDA has issued a complete response letter (CRL) for the new drug application of Ayvakit (avapritinib) for the treatment of adults with unresectable… read more.
Cassava Sciences, Inc. reported top-line results from a Phase IIb study of PTI 125, its lead investigational drug, in patients with Alzheimer’s disease. This study did not meet… read more.
ReGenTree, a U.S. joint venture company owned by GtreeBNT Co. and RegeneRx Biopharmaceuticals, announced the results of a randomized, double masked, placebo-controlled Phase III clinical trial (SEER-1) using… read more.
Bristol Myers Squibb announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the FDA for the first-line treatment of… read more.
The FDA has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab,… read more.
The FDA has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab,… read more.
Pfizer Inc. announced top-line results from a second Phase 111 study (NCT03828617), which described the safety and evaluated the consistency of immune responses elicited across three different lots… read more.
Bristol Myers Squibb and bluebird bio, Inc. announced that the companies received a Refusal to File letter from the FDA regarding the Biologics License Application (BLA) for idecabtagene… read more.
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