News
Government to Audit 81 Years of Drug Approvals for Safety Review
10+ hour, 15+ min ago (339+ words) The Government of India is preparing to review drug approvals issued over the past 81 years in an effort to strengthen medicine safety, improve regulatory oversight and update official records. The exercise will verify approvals granted since 1945, identify gaps in existing…...
Angitia reshapes bone pipeline after ending Phase III trial
13+ hour, 9+ min ago (220+ words) The Pharma Letter - Angitia reshapes bone pipeline after ending Phase III trial Angitia Biopharmaceuticals has terminated a Phase III trial of AGA111, its most advanced clinical-stage asset, about five months after raising $130 million in series D financing. The privately-held bone disease…...
FDA Mifepristone Safety Review Could Be Released Before the 2026 Midterm Elections
2+ day, 22+ hour ago (1699+ words) This is interesting: conservative outlets are reporting that the FDA could complete its so-called "safety review" of mifepristone before the midterms. The Trump administration has been slow-walking this bogus study for nearly a year'deliberately avoiding any big public moves against…...
Jackson Laboratories License Cancelled: Oxytocin Probe ka bada asar!
1+ week, 6+ hour ago (284+ words) Arre bhai, Jackson Laboratories ke Punjab aur Himachal Pradesh mein bane factory ka license cancel ho gaya hai. Rajasthan mein maternal deaths ke baad yeh oxytocin injection ki jaanch mein galat paya gaya. WHO bhi peecha kar raha hai. Isse…...
Centre invites public comments on draft amendment to rationalise residual shelf-life requirement for imported drugs - Prameya News
1+ week, 11+ hour ago (267+ words) New Delhi, June 26: The Ministry of Health and Family Welfare has published a draft notification proposing amendments to Rule 31 of the Drugs Rules, 1945, with the objective of rationalising the residual shelf-life requirement for imported drugs and further promoting Ease of…...
Govt invites public comments on draft amendment to rationalise residual shelf-life requirement for imported drugs - www. lokmattimes. com
1+ week, 17+ hour ago (274+ words) New Delhi [India], June 26: The Union Ministry of Health and Family Welfare has published a draft notification proposing amendments to Rule 31 of the Drugs Rules, 1945, with the objective of rationalising the residual shelf-life requirement for imported drugs and further promoting…...
FDA Will Reportedly Conclude Abortion Pill Safety Review by September
1+ week, 1+ day ago (563+ words) A few members of Congress have been told to expect the Food and Drug Administration's safety review of the dangerous and deadly abortion pill mifepristone to be completed by September. The review is assessing data on mifepristone to determine whether…...
FDA Backs Entera Bio's Phase 3 Plan for Oral EB613 Osteoporosis Drug
1+ week, 1+ day ago (422+ words) The Clinical Trial Vanguard FDA Backs Entera Bio's Phase 3 Plan for Oral EB613 Osteoporosis Drug Roughly 80 percent of postmenopausal women with severe osteoporosis who qualify for anabolic therapy never receive it, not because the drugs fail, but because every approved anabolic…...
Prescription Behaviors of Primary Care Providers in Osteoporosis Management: A Survey
1+ week, 6+ day ago (229+ words) Background Osteoporotic fractures impose a substantial economic burden in the United States. Although multiple pharmacologic therapies reduce fracture risk, variation exists in prescribing patterns. Internal organizational data from our institution demonstrated disproportionate utilization of denosumab compared with zoledronic acid despite…...
Balancing benefit and risk: Nisha Vora on the science of pharmacovigilance
2+ week, 15+ hour ago (319+ words) My job is to be a guardian of patient safety. As Safety Science Director, she works across both early development and post-marketing, ensuring that risks are anticipated, analyzed, and managed so treatments can reach patients responsibly. That attention does not…...