Merck Reports the US FDA’s Approval of Winrevair (Sotatercept-csrk) to Treat Adults with Pulmonary Arterial Hypertension (PAH)

Shots: The US FDA has approved Winrevair to treat adults with PAH (WHO Group 1) functional class (FC) II or III Approval was based on the global P-III (ZENITH) trial (N=172) evaluating Winrevair (n=86; 0.7 mg/kg; SC; Q3W) + background therapy vs PBO (n=86) in adults with PAH (WHO FC III/IV) at high mortality risk. WINREVAIR…

ByDipanshu DixitOctober 27, 2025

Novartis Reports Cosentyx P-III trial met 1 & 2 EPs for Patients with Polymyalgia Rheumatica (PMR)

Shots: Novartis has reported that Cosentyx met all 1 & 2 EPs in the P-III trial in adults with PMR The global P-III (REPLENISH) trial showed that Cosentyx (secukinumab) significantly improved sustained remission at Wk 52 in PMR pts vs PBO, with a reduced steroid dose and a safety profile consistent with prior use. Conducted…

ByDipanshu DixitOctober 23, 2025

Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Shots: The FDA has approved Opzelura cream 1.5% for short-term and non-continuous treatment of mild to moderate AD in non-immunocompromised children (aged≥ 2), when other topical therapies are ineffective or unsuitable sNDA approval was based on the P-III (TRuE-AD3) trial which evaluated the safety and efficacy of ruxolitinib in over 300 children receiving 0.75%, 1.5%,…

ByDipanshu DixitSeptember 19, 2025

Merck Reports the US FDA’s Approval of Winrevair (Sotatercept-csrk) to Treat Adults with Pulmonary Arterial Hypertension (PAH)

Novartis Reports Cosentyx P-III trial met 1 & 2 EPs for Patients with Polymyalgia Rheumatica (PMR)

Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

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