Apimeds Pharmaceuticals Raises $13.5 Million in IPO for Bee Venom-Based Therapy Development
Apimeds Pharmaceuticals US, Inc. has successfully completed its initial public offering, raising $13.5 million by selling 3,375,000 shares at $4.00 per share on the NYSE American exchange.
Recursion Pharmaceuticals' REC-617 Shows Promise in Advanced Solid Tumors
Recursion Pharmaceuticals presented Phase 1/2 data on REC-617, a CDK7 inhibitor, at an AACR Special Conference, showcasing its potential in treating advanced solid tumors.
Vivos Inc. Initiates First-in-Human Trial of RadioGel® for Cancer Therapy
Vivos Inc. has begun its first human clinical trial in India for RadioGel® Precision Radionuclide Therapy™ targeting cancerous lymph nodes.
Lipella Pharmaceuticals' Liposomal Delivery Platform Secures U.S. Patent, Extending Market Exclusivity
Lipella Pharmaceuticals received U.S. Patent No. 12,138,345 for its liposomal drug delivery platform, enhancing targeted therapeutic agent delivery.
McGuff Pharmaceuticals Receives FDA Approval for Santa Ana Manufacturing Facility
McGuff Pharmaceuticals, Inc. (MPI) has secured FDA approval for its 86,000-sq.-ft. sterile fill-and-finish pharmaceutical manufacturing plant in Santa Ana, CA.
Ultragenyx's GTX-102 Shows Promise in Angelman Syndrome Phase 1/2 Trial
Ultragenyx presented positive Phase 1/2 data for GTX-102, an antisense oligonucleotide targeting Angelman syndrome, at the FAST Global Science Summit.
Elite Pharmaceuticals Gains FDA Approval for Generic Vyvanse
Elite Pharmaceuticals has received FDA approval for its generic version of Vyvanse (Lisdexamfetamine Dimesylate) capsules, offering seven strengths from 10 mg to 70 mg.
Milestone Pharmaceuticals Gains New Patent for Etripamil, Prepares for Potential Launch
Milestone Pharmaceuticals received a Notice of Allowance from the USPTO for a new patent covering the repeat dose regimen of etripamil nasal spray, extending potential IP protection to July 2042.
Volixibat Receives FDA Breakthrough Therapy Designation for Cholestatic Pruritus in Primary Biliary Cholangitis
The FDA granted Breakthrough Therapy Designation to Mirum Pharmaceuticals' volixibat for treating cholestatic pruritus in patients with primary biliary cholangitis (PBC).
ARIAD Pharmaceuticals Accelerates Ponatinib to Market
ARIAD Pharmaceuticals is pushing forward with the development and approval of its new cancer drug, Ponatinib, aimed at treating resistant or intolerant chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia. With promising clinical trial results and a rolling submission for New Drug Application completed, ARIAD seeks accelerated approval from the FDA and EMA, projecting significant market potential.
Avadel Pharmaceuticals' LUMRYZ Shows Strong Growth and Receives Expanded FDA Approval
Avadel Pharmaceuticals reported $50.0 million in net revenue from LUMRYZ sales in Q3 2024, marking substantial growth in the narcolepsy treatment market.
ANI Pharmaceuticals Launches Generic Estradiol Gel Following FDA Approval
ANI Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for Estradiol Gel, 0.06%, a generic version of EstroGel.
Acurx Pharmaceuticals' Ibezapolstat Shows High Cure Rate in Phase 2 CDI Trial, Stock Plummets
Acurx Pharmaceuticals announced positive Phase 2 trial results for ibezapolstat in treating C. difficile Infection (CDI), demonstrating a 96% clinical cure rate across Phase 2a and 2b trials.
Agenus Faces Class Action Lawsuit Over Botensilimab and Balstilimab Claims
Agenus Inc. is facing a class action lawsuit on behalf of investors who purchased securities between January 23, 2023, and July 17, 2024.
Lasofoxifene Shows Promise in Neoadjuvant Breast Cancer Treatment: I-SPY 2 Trial
Lasofoxifene demonstrated a strong tolerability profile and promising Ki67 suppression in a Phase 2 study, supporting further exploration in the neoadjuvant setting.
McGuff Pharmaceuticals Receives FDA Approval for Santa Ana Manufacturing Facility
McGuff Pharmaceuticals, Inc. (MPI) has secured FDA approval for its state-of-the-art, 86,000-sq.-ft. sterile fill-and-finish pharmaceutical manufacturing plant in Santa Ana, CA.
McGuff Pharmaceuticals Receives FDA Approval for Santa Ana Manufacturing Facility
McGuff Pharmaceuticals, Inc. (MPI) has secured FDA approval for its state-of-the-art, 86,000-sq.-ft. sterile fill-and-finish pharmaceutical manufacturing plant in Santa Ana, CA.
LUMRYZ Maintains Market Exclusivity as Court Upholds FDA Approval in Narcolepsy Treatment
A U.S. District Court has affirmed the FDA's approval of Avadel Pharmaceuticals' LUMRYZ for treating cataplexy and excessive daytime sleepiness in adults with narcolepsy.
CytoDyn Advances Leronlimab Pipeline Across Oncology, Inflammation, and HIV
CytoDyn's leronlimab sees renewed progress with the FDA lifting its clinical hold in March 2024, enabling the advancement of clinical trials.
IDEAYA Biosciences Navigates Oncology Landscape with Precision Medicine Approach
IDEAYA Biosciences focuses on precision medicine in oncology, highlighted by a strong pipeline of product candidates and collaborations with major pharmaceutical companies.