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- 18/07/2019: Pharegis implemented optimized procedures for state registration of pharmaceuticals in Eurasian Economic Union.
- 20/06/2019: Pharegis updated timelines and practical approaches for Russian and EEU GMP inspection applications and procedures.
- 03/04/2019: Renewed general monographs of Russian state pharmacopeia XIV ed. have been analyzed.
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Regulatory news
Drugs.com - New Drug Approvals
- FDA Approves Inpefa (sotagliflozin) for the Treatment of Heart Failure
- FDA Approves Paxlovid (nirmatrelvir tablets and ritonavir tablets) for Adult Patients at High Risk of Progression to Severe COVID-19
- FDA Approves Yuflyma (adalimumab-aaty), a Biosimilar to Humira
- FDA Approves Xacduro (sulbactam and durlobactam) for the Treatment of Serious Infections Caused by Acinetobacter
- FDA Approves Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
News and press releases
- EMA business hours over Whit Monday, 29 May, , 26/05/2023
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 May 2023, CHMP, 26/05/2023
- EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo, CHMP, 26/05/2023
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023, CHMP, 26/04/2023
Drugs.com - Clinical Trials
- CHOP Researchers Show that IgA Fine Tunes the Body's Interactions with Microbes PHILADELPHIA, May 26, 2023....
- Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation RARITAN, NJ, May 25, 2023...
- Psilera Unveils Novel, Non-Hallucinogenic Psilocybin Derivative PSIL-006 As Lead Clinical Candidate TAMPA, Fla., May 25,...
- Sarepta Therapeutics Announces Update on Regulatory Review of SRP-9001 CAMBRIDGE, Mass.--(BUSINESS...