25 news items
Novo Nordisk is partnering with Swiss pharma company Acino to launch "Extensior" — a lower-cost version of Ozempic — in South Africa on 27 July 2026, available in 0.25mg, 0.5mg…
The FDA has proposed permanently excluding semaglutide, tirzepatide and liraglutide from the 503B Bulks List, effectively closing the last legal pathway for large-scale compounded GLP-1 production. The public comment period…
Novo Nordisk secured an interim order from the Gauteng High Court in June 2026 preventing iDexis from manufacturing and selling compounded semaglutide. iDexis is now appealing this order alongside related…
SAHPRA has approved Sun Pharma's generic semaglutide injection, a biosimilar equivalent of Ozempic, for adults with type 2 diabetes. South Africa is only the second market after India to receive…
Tirzepatide (Mounjaro), distributed by Aspen Pharmacare, has become the largest-selling pharmaceutical product in South Africa. Meanwhile, generic semaglutide is expected to become available in South Africa as early as 2027,…
Following regulatory pressure on compounded GLP-1s, Hims & Hers announced a collaboration with Novo Nordisk in March 2026, shifting its US weight loss business to focus on FDA-approved medications at…
FDA adverse event data shows over 455 reports linked to compounded semaglutide and 320 tied to compounded tirzepatide, many involving hospitalisation due to dosing errors from multi-dose vials. A 2026…
South African health regulators have issued a Class I, Type A recall of iDexis semaglutide and tirzepatide products and warned doctors and pharmacists that continued prescribing or dispensing could result…
South Africa's three major health regulatory bodies issued a joint Class I, Type A recall — the most serious safety alert level — of iDexis semaglutide and tirzepatide products, warning…
Judges on the US Court of Appeals for the Fifth Circuit questioned the legal foundations of the FDA's compounding ban during oral arguments that observers described as unusually pointed. The…
As the legal and regulatory battle over compounded GLP-1s intensifies, the FDA has been building a parallel public health case based on real-world harm data. The numbers are striking: as…
On 9 February 2026, Novo Nordisk filed a federal patent infringement lawsuit against Hims & Hers Health, the publicly traded telehealth company, alleging it had continued to mass-compound injectable semaglutide…
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