Synaptogenix gets US FDA authorization of IND application for clinical trial for Bryostatin─1 to treat multiple sclerosis

Altria's (MO) Smoke-Free Growth Underway With Latest FDA Nod

zacks.com - 24/Jun 14:20

Altria's (MO) NJOY obtains authorization from the U.S. Food and Drug Administration for menthol e-vapor products.

FDA Approves New Drug to Treat Alzheimer's, Kisunla

drugs.com - 02/Jul 19:07

TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday. In clinical trials,...

Phase 1 Clinical Trial of PMC-403 for Neovascular Age-related Macular Degeneration Advances to Both Single-dose of 4mg and Multiple-dose of 3mg

drugs.com - 02/Jul 04:07

DAEJEON, South Korea, July 2, 2024. PharmAbcine, Inc. ("PharmAbcine" or the "Company") (KOSDAQ: 208340), a clinical-stage public company developing...

SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

drugs.com - 01/Jul 06:07

STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused...

Harmony Biosciences Receives U.S. Food And Drug Administration Approval for Wakix (pitolisant) In Pediatric Patients With Narcolepsy

drugs.com - 24/Jun 23:06

PLYMOUTH MEETING, Pa., June 24, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration...

University of Nebraska Medical Center enrolls patient for RenovoRx's pivotal phase III TIGeR─PaC trial

pharmabiz.com - 28/Jun 00:00

RenovoRx, Inc, a clinical─stage biopharmaceutical company developing novel precision oncology therapies based on a local drug─delivery platform,...

Eli Lilly (LLY) Gets FDA Nod for Alzheimer's Drug Donanemab

zacks.com - 03/Jul 12:34

Eli Lilly's (LLY) Alzheimer's disease drug, Kisunla (donanemab), wins FDA approval. Kisunla will be the second drug on the market to treat the...

Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer

drugs.com - 26/Jun 04:06

BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...

Cartesian Therapeutics doses first patient in phase 2 clinical trial of Descartes─08 to treat systematic lupus erythematosus

pharmabiz.com - 04/Jul 00:00

Cartesian Therapeutics, Inc, a clinical─stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, announced that the first...

AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)

drugs.com - 25/Jun 21:06

NORTH CHICAGO, Ill., June 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food...

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