FDA Archives - Page 16 of 220

3 minute read

Seelos Therapeutics Announces Receipt Of Minutes From Its End Of Phase II Meeting With The U.S. FDA Highlighting Modifications To The Primary And Secondary Endpoints Of Its Phase II Study Of SLS-002

January 22, 9:01 AM

Company plans to continue its previously announced potential partnership discussions and expects to proceed to Phase III with SLS-002 in Adults with Major Depressive Disorder (MDD) at Imminent Risk of SuicideNEW YORK,

SEEL

1 minute read

Federal Court Allows Vanda Pharmaceuticals’ Lawsuit To Proceed Against The U.S. Food And Drug Administration

By Benzinga Newsdesk

January 19, 4:57 PM

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the United States Court of Federal Claims in Washington, D.C. denied in part the government's motion to dismiss Vanda's claim against the United

VNDA

2 minute read

Amgen’s Blockbuster Osteoporosis Drug Prolia Flagged With FDA Strictest Warning

By Vandana Singh

January 19, 2:29 PM

FDA issues serious warning on Amgen's Prolia drug, highlighting increased risk of low calcium levels in specific patient groups.

AMGN

2 minute read

Healthcare Giant Eli Lilly Under FDA Lens Again For Manufacturing Lapses

By Vandana Singh

January 19, 2:21 PM

Eli Lilly faces FDA scrutiny with eight deficiencies at its Branchburg plant, raising concerns on Emgality's manufacturing.

LLY

2 minute read

Why Is Cancer Focused Novocure Stock Trading Higher Today?

By Vandana Singh

January 18, 1:19 PM

Novocure's TTFields therapy gains FDA acceptance for non-small cell lung cancer treatment after platinum-based therapy. PMA filing under FDA review. Decision expected in 2H 2024.

NVCR

2 minute read

FDA
News

Gene Therapy For Beta-Thalassemia: CRISPR Therapeutics/Vertex’s Casgevy Secures FDA Nod Ahead of Schedule

By Vandana Singh

January 17, 8:15 AM

FDA approves CRISPR Therapeutics/Vertex's Casgevy a gene-edited cell therapy for transfusion-dependent beta-thalassemia. Vertex's swift launch strategy targets a network of treatment centers across the U.S.

BLUE

1 minute read

FDA
News

Incannex Received IRB Approval For RePOSA Phase 2/3 Clinical Trial Protocol To Assess IHL-42X Drug In Patients With Obstructive Sleep Apnea

By Charles Gross

January 17, 7:12 AM

Incannex Healthcare Inc. (NASDAQ:IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine

IXHL

1 minute read

Merck’s Crown Jewel Cancer Drug Keytruda Scores FDA Approval For Third Indication In Cervical Cancer

By Vandana Singh

January 16, 12:10 PM

FDA approves Merck's Keytruda for advanced cervical cancer. Keytruda plus chemoradiotherapy shows a 41% improvement in progression-free survival.

MRK

2 minute read

Solid Biosciences Granted FDA Orphan Drug Designation For Duchenne Muscular Dystrophy Gene Therapy Candidate SGT-003; Patient Dosing Expected To Begin Mid-To-Late Q1 2024

By Benzinga Newsdesk

January 16, 9:08 AM

– Patient dosing expected to begin mid-to-late Q1 2024 – CHARLESTOWN, Mass., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB), a life sciences company developing precision genetic medicines for

SLDB

1 minute read

FDA
News

Vanda Pharmaceuticals Responds To Recent FDA Guidance

By Benzinga Newsdesk

January 12, 1:28 PM

Communication of novel scientific findings and emerging therapies is crucial to inform healthcare providers about new treatment options that did not exist at the time of their medical training. Innovators who conduct

VNDA