⚡ Top Events Today
Axsome's Auvelity secures second FDA approval for Alzheimer's agitation, becoming first non-antipsychotic for the indication
The FDA approved an expanded use for Auvelity, marking it as the first non-antipsychotic drug approved for treating agitation associated with dementia due to Alzheimer’s disease.
Pfizer and Arvinas gain early FDA approval for breast cancer drug Veppanu despite 'underwhelming' data
The FDA granted an early, accelerated approval for the oral SERD vepdegestrant, though the partners plan to seek a third party for commercialization.
Bristol Myers Squibb's Krazati fails confirmatory Phase 3 trial, jeopardizing accelerated approval in colorectal cancer
The KRAS G12C inhibitor failed its confirmatory study in second-line colorectal cancer, putting its 2024 accelerated approval for this setting at risk of being rescinded.
Landmark FDA approval granted for first dual-vector gene therapy for hearing loss
A dual-vector gene therapy has secured its first FDA approval, a significant regulatory milestone for treating hearing loss.
FDA approves ROMVIMZA for rare joint tumor TGCT
The approval was based on safety and efficacy evidence from a single clinical trial (NCT05059262) involving 123 patients.
📁 All Events (14092 stories)
Axsome Therapeutics' Auvelity has received FDA approval for the treatment of agitation associated with Alzheimer's disease. This marks the second FDA approval for Auvelity, following its initial nod four years ago for major depressive disorder.
Axsome Therapeutics' Auvelity has received FDA approval for the treatment of agitation associated with Alzheimer's disease. This marks the second FDA approval for Auvelity, following its initial nod four years ago for major depressive disorder.
The FDA granted early approval to Veppanu, developed by Pfizer and Arvinas, for a certain breast cancer subtype. Despite this early approval, Pfizer and Arvinas intend to leave the commercialization of Veppanu to a yet-to-be-identified partner.
The FDA granted early approval to Veppanu, developed by Pfizer and Arvinas, for a certain breast cancer subtype. Despite this early approval, Pfizer and Arvinas intend to leave the commercialization of Veppanu to a yet-to-be-identified partner.
A dual-vector gene therapy for hearing loss has secured its first FDA approval. This marks a significant regulatory milestone for the treatment of hearing loss.
A dual-vector gene therapy for hearing loss has secured its first FDA approval. This marks a significant regulatory milestone for the treatment of hearing loss.
The FDA has approved ROMVIMZA for patients with TGCT. This approval was based on safety and efficacy evidence from one clinical trial (NCT05059262) involving 123 patients.
The FDA has approved ROMVIMZA for patients with TGCT. This approval was based on safety and efficacy evidence from one clinical trial (NCT05059262) involving 123 patients.
This listing includes accelerated approvals for malignant hematology and oncology indications. These approvals have postmarketing requirements for ongoing clinical trials to verify clinical benefit.
This listing includes accelerated approvals for malignant hematology and oncology indications. These approvals have postmarketing requirements for ongoing clinical trials to verify clinical benefit.
The FDA has approved vepdegestrant for the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The FDA has approved vepdegestrant for the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The FDA approved Pfizer and Arvinas' drug vepdegestrant for patients with a certain form of breast cancer on Friday. This approval was granted despite the data being described as underwhelming, leading to uncertainty about its future adoption.
The FDA approved Pfizer and Arvinas' drug vepdegestrant for patients with a certain form of breast cancer on Friday. This approval was granted despite the data being described as underwhelming, leading to uncertainty about its future adoption.
The U.S. Food and Drug Administration (FDA) has approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets. This approval is for the treatment of agitation associated with dementia due to Alzheimer’s disease in adults. Auvelity is noted as the first non-antipsychotic drug to receive this approval.
The U.S. Food and Drug Administration (FDA) has approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets. This approval is for the treatment of agitation associated with dementia due to Alzheimer’s disease in adults. Auvelity is noted
Bristol Myers Squibb's cancer drug Krazati failed its confirmatory study in second-line colorectal cancer. This failure puts its accelerated approval, granted in 2024 for this setting, at risk.
Bristol Myers Squibb's cancer drug Krazati failed its confirmatory study in second-line colorectal cancer. This failure puts its accelerated approval, granted in 2024 for this setting, at risk.
Astellas Pharma has halted two Phase 1 drug candidates and a gene therapy program. This decision is part of a pipeline restructuring, indicating a 'spring cleaning' of its early-stage assets.
Astellas Pharma has halted two Phase 1 drug candidates and a gene therapy program. This decision is part of a pipeline restructuring, indicating a 'spring cleaning' of its early-stage assets.
The FDA has granted historic approval for the first gene therapy for genetic deafness, specifically otoferlin-related hearing loss. This first-of-its-kind genetic medicine will be made available for free in the United States by Regeneron.
The FDA has granted historic approval for the first gene therapy for genetic deafness, specifically otoferlin-related hearing loss. This first-of-its-kind genetic medicine will be made available for free in the United States by Regeneron.
The FDA has placed a clinical hold on Newron Pharmaceuticals' phase 3 schizophrenia trial, halting U.S. enrollment. This decision was made following the death of a patient outside of the United States.
The FDA has placed a clinical hold on Newron Pharmaceuticals' phase 3 schizophrenia trial, halting U.S. enrollment. This decision was made following the death of a patient outside of the United States.
Intellia announced positive results from a pivotal trial of its CRISPR-based treatment for a rare disease. The treatment successfully reduced swelling attacks in patients. The results prompt discussion on the attractiveness of this one-and-done approach for patients and doctors.
Intellia announced positive results from a pivotal trial of its CRISPR-based treatment for a rare disease. The treatment successfully reduced swelling attacks in patients. The results prompt discussion on the attractiveness of this one-and-done approach for patients and doctors.
Boehringer's dual agonist survodutide demonstrated a 16.6% weight loss in a Phase 3 trial. While this result was achieved, it fell short of the competitive bar set by existing drugs. Boehringer aims to differentiate survodutide by targeting glucagon to improve its efficacy in cutting cardiometabolic risk.
Boehringer's dual agonist survodutide demonstrated a 16.6% weight loss in a Phase 3 trial. While this result was achieved, it fell short of the competitive bar set by existing drugs. Boehringer aims to differentiate survodutide by targeting glucagon to improve its efficacy in cutting cardiometabolic
The article lists accelerated approvals for malignant hematology and oncology indications that have been subsequently withdrawn by the FDA. These drugs are no longer FDA-approved.
The article lists accelerated approvals for malignant hematology and oncology indications that have been subsequently withdrawn by the FDA. These drugs are no longer FDA-approved.
The US Food and Drug Administration (FDA) approved a higher-dose version of weekly injectable semaglutide, marketed as Wegovy HD. This approval is for adults with obesity or overweight who have at least one weight-related condition.
The US Food and Drug Administration (FDA) approved a higher-dose version of weekly injectable semaglutide, marketed as Wegovy HD. This approval is for adults with obesity or overweight who have at least one weight-related condition.
Pfizer announced positive Phase 3 data for its drug Elrexfio in patients with relapsed or refractory multiple myeloma. The trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival.
Pfizer announced positive Phase 3 data for its drug Elrexfio in patients with relapsed or refractory multiple myeloma. The trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival.