Small-Cap OS Therapies Inks Commercial Manufacture Agreements For Lead Cancer Drug For Rare Type Of Bone Cancer
HER2, a HER2-targeted immunotherapy, with plans for FDA submission following promising Phase 2b data in osteosarcoma.
OS Therapies gears up for FDA meeting on cancer drug
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...
STAT1d
As officials prepare for WHO-led flu vaccine meeting, many wonder: Will the U.S. show?
Each year, flu experts from around the world gather to map out recommendations for next winter's flu vaccine. This year, it's ...
manilatimes1d
Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transplantation Meetings
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today ...
Travere Therapeutics stock soars on FDA meeting outcome
Travere Therapeutics aims to seek traditional approval based on data from the Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI, with submission expected by the end of the first quarter of 2025. The ...
STAT10h
Pharmalittle: We’re reading about FDA morale, pharma removing DEI goals, and more
Reports of impending layoffs, a buyout offer, and a return-to-office mandate have put a damper on FDA staff morale ...
JD Supra1d
From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
Neurology Advisor11h
Federal Judge Rules FDA, CDC Must Restore Health Websites Removed Under Trump Order
A federal judge has ordered the US Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) to restore access to public health websites that were removed or modified in ...
Moleculin Biotech receives positive FDA guidance for acceleration of AML trial
Moleculin Biotech (MBRX) has received FDA feedback and guidance on its IND amendment that has allowed a reduction in the size of its Phase 3 ...
Karolinska Development AB: Year-end Report - January-December 2024
Karolinska Development AB (Nasdaq Stockholm: KDEV) today publishes its Year-end Report January-December 2024. The full report is available on the Company's website. "Stronger ...
Medicus Pharma Provides Update on SKNJCT-003 Phase 2 Clinical Study for the Treatment of Nodular Basal Cell Carcinoma (BCC)
The Company Is on Track to Complete the Interim Data Analysis Before the End of Q1 2025 and to Submit the Findings to the U.S. Food and Drug Administration (FDA) Philadelphia, Pennsylvania--(Newsfile ...
Pharmabiz2d
INmune Bio to submit BLA with US FDA seeking approval of CORDStrom to treat recessive dystrophic epidermolysis bullosa in paediatric patients
Boca Raton, Florida Wednesday, February 12, 2025, 16:00 Hrs [IST] ...