RaeSedo Inc. Receives $3.4M STTR Grant to Advance Novel Asthma Therapies
RaeSedo Inc. has been awarded a $3.4 million STTR grant to further develop new asthma therapies based on Surfactant Protein-A (SP-A) derived peptidomimetics.
OmniScience and INmune Bio Partner to Accelerate Alzheimer's Clinical Trial with AI
OmniScience and INmune Bio are collaborating to enhance a Phase 2 Alzheimer's trial using OmniScience's Vivo, an AI-powered platform for real-time clinical data analysis.
FDA Approves Ziihera (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer
The FDA has granted accelerated approval to Ziihera (zanidatamab-hrii) for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC).
Glenmark Pharmaceuticals Launches Generic Vancomycin Hydrochloride Injection in US Market
Glenmark Pharmaceuticals Inc., USA has launched Vancomycin Hydrochloride for Injection USP in three dosage strengths: 750 mg, 1.25 g, and 1.5 g single-dose vials.
MIRA Pharmaceuticals to Acquire SKNY Pharmaceuticals, Expanding into $200 Billion Weight Loss and Smoking Cessation Markets
MIRA Pharmaceuticals has signed a binding letter of intent to acquire SKNY Pharmaceuticals, securing a $5 million capital infusion to advance SKNY-1, a preclinical oral drug candidate targeting obesity and smoking cessation.
Madrigal Pharmaceuticals Advances in NASH Treatment with Resmetirom Phase 3 Trials
Madrigal Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, is making significant strides in the treatment of non-alcoholic steatohepatitis (NASH) with its lead product candidate, resmetirom, currently in Phase 3 clinical trials. Despite a reduction in stock holdings by Stifel Financial Corp, the company has seen varied investment activities from other hedge funds and maintains a strong market presence with a 'Moderate Buy' rating from analysts.
Elite Pharmaceuticals Gains FDA Approval for Generic Vyvanse
Elite Pharmaceuticals received FDA approval for its Abbreviated New Drug Application (ANDA) for a generic version of Vyvanse (Lisdexamfetamine Dimesylate).
Avadel's LUMRYZ Maintains Market Exclusivity as Court Upholds FDA Approval
A U.S. District Court has affirmed the FDA's approval of Avadel Pharmaceuticals' LUMRYZ, a once-at-bedtime treatment for narcolepsy, in response to a challenge by Jazz Pharmaceuticals.
Neuropeutics Inc Wins AbbVie Biotech Innovators Award for Novel Neurodegenerative Disease Therapies
Neuropeutics Inc has been named the first recipient of the AbbVie Biotech Innovators Award for developing small molecules that prevent and reverse protein aggregation in neurodegenerative diseases.
Diagnos Inc Pursues FDA Authorization for AI-Powered Retinal Disease Detection System
Diagnos Inc announces plans to file FDA pre-market authorization for CARA SYSTEM, an AI-powered medical device designed for early detection of multiple retinal diseases.
Bora Pharmaceuticals Acquires Pyros Pharmaceuticals, Expanding Rare Disease Portfolio
Bora Pharmaceuticals has acquired Pyros Pharmaceuticals, a U.S.-based company focused on developing treatments for rare diseases, including infantile spasms.
HanAll, Daewoong, and NurrOn Announce Positive Phase 1 Results for Parkinson's Disease Therapy HL192 (ATH-399A)
HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals completed a Phase 1 study of HL192 (ATH-399A) for Parkinson's disease, meeting primary endpoints for safety and tolerability.
Elite Pharmaceuticals Receives FDA Approval for Generic Vyvanse
Elite Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for a generic version of Vyvanse (Lisdexamfetamine Dimesylate).
A1C Drink Inc. to Begin Clinical Trials of Natural Beverage for Diabetes Management
A1C Drink Inc. will commence clinical trials in early 2025 to assess its all-natural beverage's effectiveness in managing blood sugar.
ANI Pharmaceuticals Launches Ketoconazole Shampoo, 2% Following FDA Approval
ANI Pharmaceuticals has received FDA approval and launched Ketoconazole Shampoo, 2%, a generic version of Nizoral®, marking another limited competition product.
LPOXY Therapeutics Acquires Xeno Biosciences Assets to Advance C. difficile Prevention
LPOXY Therapeutics acquired key assets from Xeno Biosciences, including regulatory filings and intellectual property, to advance SIDIPREV™ for *C. difficile* prevention.
Elite Pharmaceuticals Gains FDA Approval for Generic Vyvanse
Elite Pharmaceuticals received FDA approval for its Abbreviated New Drug Application (ANDA) for a generic version of Vyvanse (Lisdexamfetamine Dimesylate).
BioAdaptives' Zeranovia Receives IRB Approval for Human Clinical Trial in Weight Management
BioAdaptives Inc. has secured IRB approval to begin a human clinical trial for Zeranovia, its weight management product, marking a significant step in its development.
Vaxart Announces Progress in Oral Vaccine Platform and COVID-19 Program
Vaxart completed two Phase 2 clinical studies for its oral norovirus vaccine candidate, establishing proof of concept for both respiratory and GI viruses.
Elite Pharmaceuticals Gains FDA Approval for Generic Vyvanse
Elite Pharmaceuticals received FDA approval for its Abbreviated New Drug Application (ANDA) for a generic version of Vyvanse (Lisdexamfetamine Dimesylate).