UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLIâ„¢ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...
The FDA just approved a new painkiller. Is it too good to be true?
Meet suzetrigine, a non-opioid that promises to avoid addiction risk. But some experts say it can't replace opioids ...
Business Wire8d
FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...
U.S. FDA approves Supernus' drug-device combination for Parkinson's disease
The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...
A first in 25 years: FDA approves new type of painkiller
The drug offers a non-addictive alternative to opioids, marking 'an important public health milestone in acute pain ...
FDA approves new pain medicine as opioid alternative. What to know about Journavx
The FDA has approved Journavx, a pain medication, offering a safer alternative to opioids. Learn about its benefits and side ...
Morningstar14d
HeartBeam Achieves Major Milestone with FDA Submission for its Groundbreaking 12-Lead ECG Synthesis Software
today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the Company’s groundbreaking 12-lead electrocardiogram (ECG) synthesis software designed ...
Business Wire20d
Zai Lab Receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of Small Cell Lung Cancer (SCLC)
--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted ... granted upon product approval. This important regulatory ...
C&EN20d
50 new drugs received FDA approval in 2024
C&EN’s tabulation follows approvals from the FDA’s Center for Drug Evaluation and Research; therefore, it does not include blood products, gene therapies, vaccines, and other therapies that ...
Popular Science21d
FDA approves first-of-its-kind nasal spray for severe depression
The decision builds on previous FDA approval for the drug’s treatment when combined with additional oral antidepressants. While Spravato’s underlying mechanisms remain unclear and only be ...
Fast Company21d
Johnson & Johnson ketamine-derived nasal spray gets FDA approval for depression, but JNJ stock dips on earnings
On Tuesday, the Food and Drug Administration (FDA) approved Johnson & Johnson’s nasal spray, Spravato (esketamine), to treat major depressive disorder. Oral antidepressants are the most common ...