2026 Compounding FDA 
The FDA Law Blog
FEBRUARY 2, 2025
This also includes additional requirements for pharmacies that engage in sterile and complex nonsterile compounding. California pharmacists are still able to provide the oral therapeutics without requiring you to visit your primary care physician through January 1, 2026.
pharmaphorum
JUNE 27, 2022
Tazverik is a first-in-class EZH2a inhibitor that was cleared by the FDA in 2020 as a third-line or later treatment for adults with relapsed or refractory follicular lymphoma (FL) whose tumours have an EZH2 mutation. Ipsen’s CVR offer includes $0.30 The post Ipsen beefs up in oncology, buying US biopharma Epizyme appeared first on.
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The FDA Law Blog
DECEMBER 3, 2023
On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.
pharmaphorum
APRIL 24, 2022
In a statement, the drugmaker said “we stand by the safety of aducanumab, and we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound.” Biogen has now drawn up its plans for the confirmatory study that could be the key to getting Aduhelm back on track.
PharmaShots
FEBRUARY 22, 2023
Some of its FDA-approved competitors include: Patents7 Eli Lilly carries big expectations from Trulicity to boost its revenue. In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026). Trulicity has been a part of over 2.8
Pharmaceutical Technology
JANUARY 10, 2023
billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%. However, Invokana is likely to continue to lose market share (forecast 9MM CAGR decline of 14.6%), due to an FDA boxed warning regarding diabetic ketoacidosis and increased risk of lower limb amputations.
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