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Podcast: LSD ‘Deserves To Reclaim Its Spot At The Lead Of The Path For Psychedelics’ Says MindMed’s R. Barrow

By Lara Goldstein
March 27, 10:25 AM
Welcome to a new episode of the Benzinga Psychedelics Podcast where we’re joined by Robert Barrow, CEO of…

MNMD

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Merck’s $11B Bet Pays As FDA Approves Sotatercept For Rare Lung Disease

By Vandana Singh
March 27, 9:20 AM
FDA approves Merck's Winrevair for PAH treatment. First-in-class therapy to enhance exercise capacity, improve WHO FC, and reduce clinical worsening. Available in select U.S. pharmacies by April. Pricing details revealed.

BMY

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ARS Pharma Readies Data In Response To FDA’s Rejection For Its EpiPen Alternative For Severe Allergic Reactions

By Vandana Singh
February 20, 3:53 PM
NAC study results by ARS Pharma comparing neffy (epinephrine nasal spray) to intramuscular injection. Data submission is expected in Q2 2024.

SPRY

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Why Is Inflammatory Disease/Oncology-Focused RAPT Therapeutics Shares Tumbling Today?

By Vandana Singh
February 20, 1:24 PM
FDA places clinical hold on RAPT Therapeutics' Phase 2 trials for zelnecirnon in atopic dermatitis and asthma.

RAPT

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ARS Pharma Announces Topline Results From Repeat Dosing Study Of neffy Under Nasal Allergen Challenge Conditions, Readies Data For Response To FDA’s Complete Response Letter

By Benzinga Newsdesk
February 20, 10:03 AM
Repeat doses of neffy under nasal allergen challenge demonstrate a pharmacokinetic profile greater than or similar to injection, and a pharmacodynamic profile greater than injection Company believes completion of

SPRY

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Avidity Biosciences Receives FDA Rare Pediatric Disease Designation For AOC 1044 For Treatment Of Duchenne Muscular Dystrophy In People With Mutations Amenable To Exon 44 Skipping

By Benzinga Newsdesk
February 20, 10:01 AM
Avidity Biosciences, Inc. (NASDAQ:RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that the U.S. Food

RNA

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Why AstraZeneca Stock Is Trading Higher Tuesday

By Vandana Singh
February 20, 9:54 AM
FDA greenlights AstraZeneca's Tagrisso combo for advanced EGFRm NSCLC. FLAURA2 Phase 3 trial results reveal a 38% reduction in progression risk with Tagrisso plus chemo, outperforming monotherapy. AstraZeneca's datopotamab deruxtecan awaits FDA decision in Q4 2024 for nonsquamous NSCLC.

AZN

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WuXi Advanced Therapies Receives FDA Approval To Manufacture Iovance’s AMTAGVI For Advanced Melanoma

By Benzinga Newsdesk
February 20, 9:35 AM
AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ -- WuXi Advanced Therapies (WuXi ATU), a wholly

IOVA

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Immuneering Receives FDA Fast Track Designation For IMM-1-104 In Pancreatic Cancer

By Benzinga Newsdesk
February 20, 9:28 AM
– Fast Track designation has the potential to accelerate lead asset IMM-1-104's path to U.S. FDA submission for pancreatic ductal adenocarcinoma – – Company expects multiple readouts from its Phase 1/2a clinical

IMRX

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Iovance Biotherapeutics to Host Conference Call And Webcast On Friday, February 16, 2024 At 4:15 p.m. ET, To Discuss The FDA Approval

By Benzinga Newsdesk
February 16, 4:40 PM
Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will host a

IOVA

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