FDA/EMA decisions, boxed warnings, pharmacovigilance, and label changes.
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(Washington Examiner) In light of an FDA-purported review of chemical abortion pills, it’s important to note that information currently with the Environmental Protection Agency is extremely relevant. The public’s exposure to an endocrine disruptor in our drinking water deserves consideration.
Brussels: The European Commission has made legally binding a set of commitments offered by French pharmaceutical company Sanofi to address preliminary concerns over potentially misleading communications about a competing influenza vaccine in Germany and France. The case centres on Fluad,…
The European Commission has made commitments offered by Sanofi legally binding under EU antitrust rules. The commitments relate to the Commission's preliminary competition concerns relating to Sanofi's alleged disparagement campaigns in Germany and France against Fluad, the only enhanced flu…
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. 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…
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 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.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…
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…
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…