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.
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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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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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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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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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 previously disclosed goal date will not be met due to “heavy workload and limited resources.”
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Ibtrozi provides a new treatment option for patients with advanced ROS1+ NSCLC, a rare and aggressive form of lung cancer.
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In total, two phase 2/3 trials are included in the hold, as well as three additional phase 1 trials of either agent and/or their combinations.
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Enlicitide demonstrated statistically significant and clinically meaningful reductions in cholesterol in a pair of phase 3 trials.
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Widaplik is the first and only FDA-approved triple combo med for use as initial therapy in patients who need multiple drugs to achieve blood pressure goals.
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Nugevia products will bring a clinical-grade standard to the nutraceutical space.
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Bayer’s oral androgen receptor inhibitor, Nubeqa, in combination with ADT, is now approved for metastatic castration-sensitive prostate cancer.
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The proactive approach exemplifies a new treatment strategy in oncology, redefining how we think about drug resistance in breast cancer.
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