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Approvals, Safety & REMS
FDA/EMA decisions, boxed warnings, pharmacovigilance, and label changes.
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Latest in Approvals, Safety & REMS
FDA expects to draft mifepristone safety review next year; pro-life groups call it ‘insufficient’
3+ day, 11+ hour ago (571+ words) WASHINGTON (OSV News) — The Food and Drug Administration’s safety review of mifepristone is expected to stretch into next year, according to an Oct. 7 court filing, prompting disappointment from pro-life groups. In a court-ordered status update on the review, the FDA…...
Lexaria Bioscience Corp Receives Independent Review Board Approval to Begin Human Pilot Study 7
4+ day, 11+ hour ago (470+ words) Lexaria Bioscience Corp. had received ethics approval from an independent review board, for Human Pilot Study #7 that will evaluate two oral DehydraTECH-semaglutide compositions against Novo... had received ethics approval from an independent review board, for Human Pilot Study #7 (GLP-1-H26-7) that…...
FDA Must Do Comprehensive Study on How Abortion Pills Hurt Women
6+ day, 17+ hour ago (514+ words) The Food and Drug Administration faces a court-ordered Oct. 7 deadline to update its study of the abortion drug mifepristone, and pro-life leaders say that review will fail women unless it counts the injuries already on record. SBA Pro-Life America President…...
Fidson wins Roche-backed licence to make generic influenza drug for 129 countries
1+ week, 2+ day ago (812+ words) Fidson Healthcare Plc, a Nigerian pharmaceutical manufacturer, has been selected by the Medicines Patent Pool (MPP) as one of 11 manufacturers that will develop and produce generic versions of Roche’s baloxavir marboxil, potentially expanding access to the influenza treatment across 129 eligible…...
BTL Expands EXOMIND® Platform with New FDA Clearances - AOL
1+ week, 3+ day ago (484+ words) BTL Expands EXOMIND® Platform with New FDA Clearances AOL.ca MARLBOROUGH, Mass., Oct. 1, 2026 /PRNewswire/ -- BTL Industries, a global leader in medical and wellness technologies, today announced expanded FDA clearances for EXOMIND(r), its noninvasive brain stimulation platform. EXOMIND(r) entered…...
Lantheus Announces CMS Grants Transitional Pass-Through Status for PYLARIFY® TruVu (piflufolastat F 18)
1+ week, 4+ day ago (262+ words) Designation, together with a permanent HCPCS code effective October 1, 2026, supports patient access and reimbursement for PYLARIFY TruVu, Lantheus' PSMA PET imaging agent PYLARIFY TruVuTM (piflufolastat F 18) Injection PYLARIFY TruVuTM (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a…...
EU clears first drug therapy for rare disease cALD
2+ week, 2+ day ago (566+ words) Neuraxpharm and Minoryx Therapeutics' Nezglyal has become the first approved drug therapy in the EU for rare neurodegenerative disease cerebral adrenoleukodystrophy (cALD), and is set to launch before the end of the year. The green light from the European Commission…...
Chronic Kidney Disease Market: 5 Emerging Therapies to Watch as the Treatment Landscape Expected to Evolve by 2036 | DelveInsight
2+ week, 3+ day ago (211+ words) 24 Sep, 2026, 14:31 GMT Although SGLT2 inhibitors, non-steroidal MRAs, and RAS blockade have been approved, a significant proportion of CKD patients continue to progress to kidney failure, while the disease remains substantially underdiagnosed. This highlights the need for more effective therapies to slow…...
Vertex makes case for broader use of kidney disease candidate
2+ week, 5+ day ago (11+ words) firstwordpharma.com...
License GONE: Abortion Pill Triggers Instant Shutdown
2+ week, 5+ day ago (435+ words) Texas regulators stripped a doctor’s license after he prescribed an abortion-inducing drug, enforcing a state law that mandates revocation. Story Highlights The Texas Medical Board revoked Dr. William Evans’ license effective September 4, 2026. The board cited an inappropriate sexual relationship with…...