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Rhythm Pharmaceuticals
NEWS

Rhythm Pharmaceuticals Reports the EC Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Shots: The EC has approved label expansion of Imcivree to incl. treatment of obesity & control of hunger in pts (≥4yrs.) with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment; commercial launch is expected in 2027 Approval was supported 120-patient cohort data from the global P-III (TRANSCEND) trial assessing setmelanotide (n=81) vs PBO…
May 4, 2026

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NEWS

Arvinas and Pfizer Report the US FDA Approval of Veppanu (Vepdegestrant) for ESR1-Mutated Breast Cancer

Shots: FDA approved Veppanu to treat adults with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer who received ≥1L of endocrine therapy, prior to PDUFA date of Jun 5, 2026; Arvinas & Pfizer plan to select a third-party partner for commercialization NDA was backed by P-III (VERITAC-2) trial assessing Veppanu alone vs fulvestrant in mentioned pts…
May 4, 2026

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NEWS

Theradaptive Receives US FDA Approval to Initiate P-III Trial of OsteoAdapt SP for Spinal Fusion Procedures

Shots: The US FDA has approved initiation of the P-III (OASIS) trial evaluating OsteoAdapt SP as an alternative to autologous & allograft bone graft in TLIF, ALIF, and LLIF procedures for symptomatic degenerative lumbosacral spine disease This approval builds on prior clinical experience in ~100 participants & expanded enrollment in Australia & Israel, while the…
May 1, 2026

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Axsome
NEWS

Axsome Therapeutics Reports the US FDA Approval of Auvelity to Treat Agitation Associated with Alzheimer’s Dementia

Shots: The US FDA has approved Auvelity (dextromethorphan HBr & bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease Approval was supported by an extensive clinical program incl. P-III (ADVANCE-1 & ACCORD-2), where ADVANCE-1 evaluated Auvelity vs PBO or bupropion over 5wks., while ACCORD-2 assessed Auvelity vs PBO in known responders In…
May 1, 2026

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Pfizer New
NEWS

Pfizer Reports the P-III (MagnetisMM-5) Trial Data on Elrexfio (Elranatamab) for R/R Multiple Myeloma (MM)

Shots: Pfizer has reported the P-III (MagnetisMM-5) trial data assessing Elrexfio monotx. (SC) vs daratumumab + pomalidomide & dexamethasone for the treatment of adults (n= 497) with r/r MM who received prior ≥1L of treatment Trial met its 1EP of improved PFS, as assessed by BICR, while OS data (2EP) remain immature & is under assessment; data…
May 1, 2026

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Hutchmed
NEWS

HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

Shots: The Chinese NMPA has accepted NDA & granted priority review to HUTCHMED's sovleplenib for the treatment of adults with warm antibody autoimmune hemolytic anemia (wAIHA) who had an inadequate response to ≥1 previous glucocorticoid treatment NDA was supported by the Chinese P-II/III (ESLIM-02) assessing sovleplenib vs PBO in adults with primary or secondary wAIHA who had…
April 29, 2026

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Astrazeneca
NEWS

AstraZeneca Reports US FDA Approval of Breztri Aerosphere for Asthma

Shots: The US FDA has approved AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) for the maintenance treatment of asthma in pts (≥12yrs.); regulatory review is ongoing in the EU, Japan & China Approval was based on the P-III (LOGOS & KALOS) trials evaluating Breztri Aerosphere vs PT009, Symbicort, and PT009 + Symbicort in ~4,300…
April 28, 2026

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