Regeneron Wins US FDA Approval for Eylea HD with Up to 5-Month Dosing in wAMD and DME

Shots: FDA has approved extending Eylea HD dosing intervals up to 20wks. for wet age-related macular degeneration (wAMD) & diabetic macular edema (DME) after 1yr. of response based on visual & anatomic outcomes As a part of approval, the Eylea HD label will incl. 96wk. PULSAR (wAMD; n=583) & PHOTON (DME; n=395) data, where 71%…

ByRidhi RastogiApril 6, 2026

NEWS

Eli Lilly Reports US FDA Approval of Foundayo (Orforglipron) for Weight Loss

Shots: FDA has approved Foundayo along with lifestyle intervention for obese/overweight adults with weight-related medical problems; Foundayo will be available via LillyDirect beginning Apr 6, 2026 Approval was backed by the ATTAIN program, incl. ATTAIN-1, where Foundayo showed weight loss of 27.3 lbs (12.4%) vs 2.2 lbs (0.9%) with PBO at the highest dose, with…

ByRidhi RastogiApril 2, 2026

NEWS

GSK Reports the NMPA Approval of Exdensur (Depemokimab) for Severe Asthma

Shots: The Chinese NMPA has approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) characterised by an eosinophilic phenotype based on P-III (SWIFT-1: n=382) & (SWIFT-2: n=380) trials Exdensur reduced asthma exacerbations by 58% (SWIFT-1) & 48% (SWIFT-2) over 52wks., with results in Chinese pts (n=58, SWIFT-1) consistent with the overall population. Pooled data…

ByRidhi RastogiApril 1, 2026

NEWS

Teva Advances Biosimilars Portfolio with Ponlimsi (Denosumab) FDA Approval and Dual Omalizumab Filing Acceptance

Shots: The US FDA has approved Ponlimsi, a biosimilar version of Prolia (denosumab), for all indications of the reference product Approval was based on extensive clinical data, incl. analytical & clinical studies, which showed comparable efficacy, safety, & immunogenicity of Ponlimsi to the reference product Additionally, Teva’s biosimilar of Xolair (omalizumab) was accepted for review…

ByRidhi RastogiMarch 31, 2026

NEWS

Novo Nordisk’s Awiqli Receives the US FDA Approval for Type 2 Diabetes

Shots: The US FDA approved Awiqli (insulin icodec-abae; 700 units/mL) to improve glycaemic control in adults with type 2 diabetes as an adjunct to diet & exercise, with Novo planning a US launch in the FlexTouch device in H2’26 Approval was based on the P-IIIa (ONWARDS) program assessing Awiqli (QW) vs basal insulin (QD) in…

ByRidhi RastogiMarch 27, 2026

NEWS

Corcept Therapeutics Reports the US FDA Approval of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has approved Lifyorli (relacorilant) + nab-paclitaxel for the treatment of adults with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic therapies, ≥1 of which included Avastin NDA was supported by P-III (ROSELLA) assessing Lifyorli + nab-paclitaxel vs nab-paclitaxel alone in the above-mentioned pts (n=381) with no…

ByRidhi RastogiMarch 26, 2026

NEWS

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Shots: The Japanese MHLW has approved Dupixent to treat adults with mod. to sev.bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks. Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks. 4 to 6 if disease control was…

ByRidhi RastogiMarch 25, 2026

NEWS

Novo Nordisk Reports the US FDA Approval of Wegovy HD for Weight Management

Shots: FDA has approved Wegovy HD (7.2mg semaglutide, QW) under CNPV along with lifestyle intervention for chronic weight management in adults with obesity; Wegovy HD will be launched as a single-dose pen by Apr 2026 Backed by STEP UP trial (~1,400 adults without T2D) & STEP UP T2D trial (~500 obese adults with T2D), based…

ByRidhi RastogiMarch 23, 2026

NEWS

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

Shots: The US FDA has approved Imcivree for the treatment of pts (≥4yrs.) with acquired hypothalamic obesity (HO) Approval was supported by the global P-III (TRANSCEND) trial assessing setmelanotide (n=94) vs PBO (n=48) in 142 pts with acquired HO Trial met its 1EP with a 18.4% PBO-adjusted reduction in BMI, showing -15.8% vs +2.6% mean…

ByRidhi RastogiMarch 20, 2026

NEWS

GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: The US FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in PBC pts; regulatory reviews in the EU, UK, Canada & China are ongoing Approval was supported by P-III (GLISTEN) trial assessing Lynavoy (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus Trial met its 1EP & key 2EPs showing…

ByRidhi RastogiMarch 20, 2026

Regeneron Wins US FDA Approval for Eylea HD with Up to 5-Month Dosing in wAMD and DME

Eli Lilly Reports US FDA Approval of Foundayo (Orforglipron) for Weight Loss

GSK Reports the NMPA Approval of Exdensur (Depemokimab) for Severe Asthma

Teva Advances Biosimilars Portfolio with Ponlimsi (Denosumab) FDA Approval and Dual Omalizumab Filing Acceptance

Novo Nordisk’s Awiqli Receives the US FDA Approval for Type 2 Diabetes

Corcept Therapeutics Reports the US FDA Approval of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Novo Nordisk Reports the US FDA Approval of Wegovy HD for Weight Management

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

GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Contact US

FOLLOW US