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Complete response letters
Fortress, Sentynl Fail To Secure FDA Nod in Rare Pediatric Disease
As with recent rejections for Biogen and Scholar Rock, manufacturing issues stymied a regulatory bid from Fortress Biotech and Sentynl Therapeutics. Fortress said the FDA did not flag problems with the drug’s safety or efficacy.
October 1, 2025
·
2 min read
·
Tristan Manalac
Government
US Government Shuts Down, FDA Closed for New Applications
Due to policies regarding industry user fees, the FDA will not be able to accept any new drug applications for the duration of the government shutdown, according to Leerink Partners.
October 1, 2025
·
4 min read
·
Annalee Armstrong
Press Releases
Scryb Grants Stock Options
October 1, 2025
·
2 min read
Press Releases
Former Canadian Coatings Association President & CEO Gary LeRoux joins Biosenta’s Advisory Board
Veteran paint and coatings industry leader brings decades of executive and regulatory expertise to support commercialization of Tri-Filler(R) antimicrobial technology
October 1, 2025
·
3 min read
Press Releases
PharmaTher Announces Sale of Ketamine ANDA with Potential to Generate over US$25 Million in Milestone and Profit-Sharing Payments
October 1, 2025
·
5 min read
Press Releases
Envoy Medical to Participate in the American Academy of Otolaryngology Head and Neck Surgery (AAO-HNSF) Conference on October 11th-14th
October 1, 2025
·
7 min read
Press Releases
Sernova Biotherapeutics Announces $13 Million Debt-to-Equity Conversion Eliminating Significant Financing Overhang
October 1, 2025
·
5 min read
Press Releases
ENTERO THERAPEUTICS (ENTO) Acquires 100% of GRID AI, a Grid-Edge AI Platform Optimizing Next-Gen Power Demand
Transaction positions ENTO in the high-growth AI energy-infrastructure market, amid a surge of multi-billion-dollar hyperscaler spending on data centers, and rapid growth in behind-the-meter energy storage solutions
October 1, 2025
·
5 min read
Press Releases
Liquid Filtration for Pharmaceutical Market Competitive and Value Chain Analysis Insight
October 1, 2025
·
1 min read
Press Releases
Anti Fungal Drugs Market Outlook 2025–2032: Strong CAGR of 3.5% with USD 19.08 Billion Valuation
October 1, 2025
·
1 min read
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