Delivers up-to-date industry news on topics like drug approvals, product recalls, company expansions and acquisitions, market trends for all OSD forms, as well as excipients, packaging and supply chain issues. Monitors market trends in specific drug categories as well as in supplements/nutraceuticals. Provides updates on clinical trials. Includes alerts about new or upcoming regulatory issues.
Ibtrozi provides a new treatment option for patients with advanced ROS1+ NSCLC, a rare and aggressive form of lung cancer.
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The previously disclosed goal date will not be met due to “heavy workload and limited resources.”
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Supernus will buy Sage through a tender offer for $8.50 per share in cash, picking up Sage’s novel oral postpartum depression medicine.
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The Commissioner’s National Priority Voucher program says it will shorten drug review times from approximately 10-12 months to 1-2 months.
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A single dose of COMP360 demonstrated a statistically significant and clinically meaningful reduction in symptom severity in treatment-resistant depression.
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The once-daily pill, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines in complete phase 3 results.
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Nuvalent will initiate a rolling NDA submission in July for its oral tyrosine kinase inhibitor in TKI pre-treated patients with advanced ROS1-positive NSCLC.
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The company shared positive results from a phase 2b trial of its AI-designed oral GLP-1 receptor agonist, MDR-001, in adults with obesity or overweight.
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According to the company, a third-party manufacturing vendor of its main CDMO was cited for deficiencies following a CGMP inspection.
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Per a June 26 WARN notice, the layoffs will take effect on August 22 and will include the company’s 338 full-time employees.
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The study highlights how AI tools like ChatGPT are shaping reputation and consumer perception of OTC brands.
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The MEAI-based oral candidate is a novel psychoactive aminoindane derivative that exerts a euphoric, alcohol-like experience.
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Torrent will buy KKR’s 46.39% equity stake in J. B. Chemicals and Pharmaceuticals in a deal worth roughly $1.38 billion.
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Zegfrovy is the only approved targeted oral treatment for NSCLC with EGFR exon20ins.
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The approval comes after rumors swirled that agency head Marty Makary initially directed staff members to issue a complete response letter.
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