Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: The EC has approved Dupixent to treat mod. to sev. CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment & naïve to anti-IgE therapy based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, and CUPIDKids Study A & C assessed Dupixent (LD → 300mg Q2W or 200mg Q2W for…

ByDipanshu DixitApril 13, 2026

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Eli Lilly Launches Foundayo (Orforglipron) for Weight Loss in the US

Shots: Eli Lilly has reported that Foundayo is now available in the US, along with lifestyle intervention for obese/overweight adults with weight-related medical problems. Foundayo is now available via LillyDirect and telehealth, with US retail rollout starting today Approval was backed by the ATTAIN program, including ATTAIN-1 (n= 3127), where Foundayo showed weight loss of…

ByDipanshu DixitApril 13, 2026

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DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer

Shots: China’s National Medical Products Administration has accepted the BLA for DualityBio’s trastuzumab pamirtecan (T-Pam; DB-1303/BNT323), an investigational ADC, for the second-line treatment of unresectable or metastatic HER2+ breast cancer The application is supported by interim results from the pivotal P-III (DB-1303-O-3001) trial, which met its primary endpoint, demonstrating statistically significant improvement in PFS vs…

ByPrince GiriApril 10, 2026

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Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN

Shots: Health Canada has approved Empaveli (pegcetacoplan) for patients (≥12yrs.) with C3 glomerulopathy (C3G) or primary IC-MPGN to reduce proteinuria, marking the first approved therapy for these indications in Canada Approval was based on the P-III (VALIANT) study, where Empaveli demonstrated a 68% reduction in proteinuria (uPCR), stabilization of kidney function, and clearance of C3…

ByPrince GiriApril 10, 2026

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Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging

Shots: The US FDA has accepted the resubmitted NDA for TLX101-Px (Pixclara; 18F-FET), an investigational PET imaging agent for the detection and characterization of glioma in adult and pediatric patients The US FDA has assigned a PDUFA date of 11’Sep, 2026; TLX101-Px has received Orphan Drug and Fast Track designations, addressing unmet needs in distinguishing…

ByPrince GiriApril 10, 2026

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Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada

Shots: Sanofi became the Nuvaxovid market authorization holder in Canada to supply the protein-based COVID-19 vaccine. Nuvaxovid to be available in Canada for the fall 2026-2027 season Authorization was supported by pivotal P-III trials demonstrating ~90% efficacy of Nuvaxovid in preventing symptomatic COVID-19. Demonstrated a favourable tolerability profile, supporting its use for seasonal vaccination Nuvaxovid…

ByDipanshu DixitApril 9, 2026

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Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Shots: The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…

ByRidhi RastogiApril 8, 2026

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GSK’s Exdensur (Depemokimab) Receives the NMPA Approval for CRSwNP

Shots: The NMPA has approved Exdensur as an add-on therapy for adults with CRSwNP for whom therapy with systemic corticosteroids & /or surgery do not provide adequate disease control, based on P-III (ANCHOR 1 & 2) trials The ANCHOR-1 & ANCHOR-2 trial assessed Exdensur(Q6M)+ intranasal corticosteroids (SoC) vs PBO + SoC in 271 & 257 pts,…

ByRidhi RastogiApril 8, 2026

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The US FDA Accepts Ultragenyx’s Resubmitted BLA for UX111 in Sanfilippo Syndrome Type A

Shots: The US FDA has accepted the resubmitted BLA of UX111 (rebisufligene etisparvovec) for accelerated approval in Sanfilippo syndrome Type A (MPS IIIA), with a PDUFA action date of Sep 19, 2026 UX111 BLA is supported by up to 8yrs. of follow-up data showing durable clinical benefit & acceptable safety. Also, during prior late-cycle review,…

ByRidhi RastogiApril 6, 2026

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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

Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Eli Lilly Launches Foundayo (Orforglipron) for Weight Loss in the US

DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer

Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN

Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging

Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada

Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

GSK’s Exdensur (Depemokimab) Receives the NMPA Approval for CRSwNP

The US FDA Accepts Ultragenyx’s Resubmitted BLA for UX111 in Sanfilippo Syndrome Type A

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

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