United States — Food and Drug Administration & Sun Pharma
11 shared events · Importance 3 · Last updated Aug 19, 2026
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Regulatory
United States — Food and Drug Administration: The FDA accepted the NDA and granted Priority Review, setting a PDUFA date in Q1 2027; its decision will determine ecopipam's market availability.
Sun Pharma: Teva is the developer and sponsor of ecopipam; the FDA acceptance advances its neuroscience pipeline and growth strategy, with shares rising in pre-market trading.
Aug 19, 2026 · 7 articles
Regulatory
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> accepted the Biologics License Application for AVT16, initiating the review process for this proposed interchangeable biosimilar.
Sun Pharma: Sun Pharma>>> is responsible for the commercialization of AVT16 under a partnership with Alvogen>>>, which could expand its product portfolio if approved.
Jun 08, 2026 · 11 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> (FDA) is the regulatory body reviewing Alvogen's resubmitted applications for AVT05 and AVT06. Their decision will determine the market entry of these biosimilars in the United States>>>.
Sun Pharma: Sun Pharma>>> is partnered with Alvogen>>> for the commercialization of AVT05 and AVT06. The resubmission of BLAs by Alvogen>>> is a positive development for Sun Pharma>>> as it moves closer to potentially commercializing these biosimilars.
Jun 04, 2026 · 10 articles
Business
United States — Food and Drug Administration: Sun Pharma filed three ANDAs and received approvals for six during the quarter, with 119 ANDAs awaiting FDA approval, reflecting ongoing regulatory engagement.
Sun Pharma: Sun Pharma reported a 27% rise in Q1 net profit and 10.5% revenue growth, driven by India and innovative medicines, while US generics declined. The company is progressing on its Organon acquisition, expected to close in early 2027.
Jul 31, 2026 · 7 articles
Business
United States — Food and Drug Administration: The FDA granted Fast Track designation for TEV-408 in celiac disease, supporting accelerated development.
Sun Pharma: Teva is the developer of TEV-408 and announced the Phase 2b advancement, which supports its pipeline and growth strategy, positively impacting its stock.
Jul 07, 2026 · 7 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration granted Ecopipam Orphan Drug and Fast Track designations for pediatric Tourette syndrome, indicating its potential importance in addressing an unmet medical need.
Sun Pharma: Sun Pharma acquired Emalex Biosciences, strengthening its late-stage neuroscience pipeline with Ecopipam and advancing its Pivot to Growth strategy. This acquisition is expected to support near- and long-term growth for Sun Pharma.
Jun 10, 2026 · 8 articles
Regulatory
United States — Food and Drug Administration: The FDA is the regulatory authority that completed the first-cycle review of NRx's ANDA, a critical step in the approval process for the company's ketamine product.
Sun Pharma: Teva is mentioned as the former employer of Chaim Hurvitz, providing context to his background but not directly involved in this event.
Aug 07, 2026 · 6 articles
Regulatory
United States — Food and Drug Administration: Regulator whose briefing documents and advisory committee vote triggered the stock collapse and legal actions.
Sun Pharma: Teva is mentioned only as a past success for BFA, not directly involved in this event.
Jul 27, 2026 · 293 articles
Business
United States — Food and Drug Administration: The FDA approved Palsonify in 2025, enabling its commercial availability. The agency's regulatory decisions are relevant to the value of the acquired assets.
Sun Pharma: Mentioned as part of 2026 M&A activity; acquired Organon for $11.75B.
Jul 06, 2026 · 34 articles
Regulatory
United States — Food and Drug Administration: The United States — Food and Drug Administration classified the recall as Class II and is overseeing the process, ensuring patient safety and regulatory compliance.
Oct 29, 2025 · 8 articles
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