⚡ Top Events Today
Axsome's Auvelity Gains FDA Approval for Alzheimer's Agitation
The FDA approved Auvelity for the treatment of agitation associated with Alzheimer's disease, its second approved indication.
Pfizer and Arvinas Secure Early FDA Approval for Breast Cancer Drug Veppanu
The FDA granted early approval for Veppanu for a certain subtype of breast cancer.
Landmark FDA Approval for First Gene Therapy Targeting Hearing Loss
A dual-vector gene therapy for hearing loss has received its first FDA approval.
Merck's Keytruda Combo Gains Full FDA Approval in HER2+ Gastric Cancer
The FDA granted traditional approval for Keytruda in combination with trastuzumab and chemotherapy for first-line treatment of locally advanced or metastatic HER2-positive gastric cancer (PD-L1 CPS ≥1).
AstraZeneca's KOSELUGO Approved for Younger Pediatric Patients with NF1
The FDA approved KOSELUGO for pediatric patients aged 1 year and older with NF1 who have symptomatic, inoperable plexiform neurofibromas.
📁 All Events (14127 stories)
On September 10, 2025, the FDA approved selumetinib (KOSELUGO) from AstraZeneca Pharmaceuticals LP. This approval is for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
On September 10, 2025, the FDA approved selumetinib (KOSELUGO) from AstraZeneca Pharmaceuticals LP. This approval is for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
On March 19, 2025, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy. This approval is for locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1).
On March 19, 2025, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy. This approval is for locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma expr
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