Imricor starts global trial for US FDA approval

‘Transformative event’: Clinical dermatology firm Botanix gets US FDA nod for sweat-stopper gel

thewest.com.au - 20/Jun 02:30

Clinical dermatology company Botanix has secured US Food and Drug Administration approval for its gel aimed at treating excessive sweating.

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

pharmabiz.com - 01/Jul 00:00

Synaptogenix, Inc., an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, announced that the Food & Drug...

FDA Approves Sofdra (sofpironium) Topical Gel for the Treatment of Primary Axillary Hyperhidrosis

drugs.com - 20/Jun 04:06

Philadelphia and Phoenix US, 20 June 2024 -- Clinical dermatology company, Botanix Pharmaceuticals Ltd. (ASX:BOT, Botanix or the Company), is pleased...

Genting and TauRx applying for UK, US regulators' approval for Alzheimer's drug

nst.com.my - 20/Jun 21:55

KUALA LUMPUR: Genting Bhd, along with its partner TauRx Pharmaceuticals Ltd., is currently seeking approval from both the United Kingdom's Medicines...

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...

Perth biotech Botanix to raise $70m following FDA nod for sweat-stopper gel

thewest.com.au - 21/Jun 03:24

Biotech Botanix says it has received firm commitments to raise $70 million from institutional investors just a day after it received US Food and Drug...

Sarepta Therapeutics Announces Expanded US FDA Approval of Elevidys to Duchenne Muscular Dystrophy Patients Ages 4 and Above

drugs.com - 20/Jun 23:06

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 20, 2024-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare...

FDA Expands Approval for Duchenne Muscular Dystrophy Gene Therapy

drugs.com - 24/Jun 21:21

MONDAY, June 24, 2024 -- The U.S. Food and Drug Administration has expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene...

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)...

Monthly News Roundup - June 2024

drugs.com - 30/Jun 00:06

FDA Grants Expanded Approval to Skyrizi for Ulcerative Colitis On June 18th, the U.S. Food and Drug Administration (FDA) approved AbbVie’s...

Rubriques :