Biotechnology News

Delcath Systems, Inc. (DCTH) announced the FDA has accepted its new drug application resubmission for HEPZATO Kit seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma. The FDA consider the submission a complete class 2 response. The PDUFA date for...
Biopharmaceutical company Cyclerion Therapeutics, Inc. (CYCN) announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to zagociguat (previously CY6463) for the treatment of mitochondrial diseases. Zagociguat is the first CNS-penetrant sGC stimulator to be developed...
BrainStorm Cell Therapeutics Inc. (BCLI) announced the FDA will hold an Advisory Committee Meeting to discuss the company's Biologics License Application for NurOwn for the treatment of amyotrophic lateral sclerosis. BrainStorm requested that the Center for Biologics Evaluation and Research utilize the...
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Biogen Inc. (BIIB) reported Phase 1b clinical data showing that the investigational antisense oligonucleotide therapy, BIIB080, reduced soluble tau protein in cerebrospinal fluid in a dose-dependent and sustained manner in patients with early-stage Alzheimer's disease. BIIB080 also reduced aggregated...
Viking Therapeutics Inc. (VKTX), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced Tuesday positive results from Phase 1 clinical trial of Dual GLP-1/GIP Receptor Agonist VK2735. Based on these results from Phase 1 single ascending dose or SAD and multiple...
Monopar Therapeutics Inc. (MNPR) announced completion of a pre-specified interim analysis for its Validive Phase 2b/3 VOICE trial for the prevention of severe oral mucositis in patients undergoing chemoradiotherapy for oropharyngeal cancer. The trial did not meet the pre-defined threshold for efficacy...
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handsanitizer mar29

Canton, South Dakota-based Jarman's Midwest Cleaning Systems, Inc. is recalling certain hand sanitizer non-sterile solution due to the presence of methanol, the U.S. Food and Drug Administration said. The recall includes all lots of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution

hotdogbuns mar23

Fort Wayne, Indiana-based Perfection Bakeries D/B/A Aunt Millie's is recalling 8 ct. packages of Our Family White Hot Dog Buns citing the possible presence of undeclared sesame, a known allergen, the U.S. Food and Drug Administration said. The product comes in a printed plastic package marked with "Our Family Hot Dog Buns 8 ct." on the top and has a blue twist tie.

ascendlaboratorie mar23

Parsippany, New Jersey -based Ascend Laboratories LLC. is recalling Dabigatran Etcxilate capsules citing the detection of N-Nitrosodimethylamine or NDMA impurity, a probable human carcinogen, the U.S. Food and Drug Administration said. The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.

organicstrawberries mar17

California Splendor, Inc. is recalling certain lots of 4-lb. bags of Kirkland Signature Frozen Organic Strawberries citing risk of Hepatitis A, the U.S. Food and Drug Administration said. The affected products were sold by Costco in Los Angeles, Hawaii and two San Diego business centers.

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Results Date Company Name Ticker Event Indication Outcome
Jun 2023 MoonLake Immunotherapeutics MLTX Top line results from Phase 2 trial of Sonelokimab (MIRA) Hidradenitis Suppurativa
May 2023 PTC Therapeutics Inc. PTCT Results from phase III trial of Sepiapterin (PTC923) (APHENITY) Phenylketonuria
Mid 2023 COMPASS Pathways plc CMPS Preliminary data from Phase II trial of CTX-009 Metastatic Colorectal Cancer Pending
Mid 2023 Bellerophon Therapeutics LLC BLPH Top-line data readout from INOpulse REBUILD phase III trial Fibrotic interstitial lung disease
Mid 2023 PROKIDNEY CORP. PROK Initial interim data from phase II trial of REACT (REGEN-007) Type 1 or 2 diabetes and chronic kidney disease
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Keep on top of the news affecting biotech and pharma companies. Stay informed about new developments and trends, as well as decisions made by the FDA, with the latest updates from this comprehensive source of biopharma industry news.

The World Health Organization's Strategic Advisory Group of Experts on Immunization (SAGE) revised the roadmap for prioritizing the use of Covid-19 vaccines to reflect the impact of Omicron and high population-level immunity acquired by infection and vaccination. WHO experts recommended that healthy kids and teenagers are considered as "low risk" category and may not necessarily need vaccine aga
President Joe Biden has signed the Covid Origins Act of 2023 into law. The legislation requires the Biden administration to declassify intelligence related to any potential links between the Wuhan Institute of Virology and the origins of the Covid pandemic within 90 days of enactment.
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As another month draws to a close, it is time to reflect on recent regulatory developments that have made headlines and look ahead to what's in store in March, which is observed as the National Kidney Month.
As we move into the shortest month of the year, let's take a look at some of the regulatory news reported during January and look ahead to what's in store for February.
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AN2 Therapeutics Inc. (ANTX) currently trades around $10, having lost more than 50% from its all-time high of $23.58 reached last May.
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