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 Rastogi7 hours ago

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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 Rastogi12 hours ago

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Merck Receives the EC Approval for Keytruda, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Shots: The EC has approved Keytruda/Keytruda SC + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapies, in all 30 EEA member states Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda…

ByRidhi Rastogi4 days ago

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Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for Gastrointestinal Stromal Tumors (GIST)

Shots: The US FDA has received NDA of bezuclastinib under the RTOR program for the treatment of pts with GIST who were previously treated with imatinib, backed by the P-III (PEAK) trial of bezuclastinib + sunitinib vs sunitinib monotx. Trial met its 1EP of improved PFS by 50% (mPFS: 16.5 vs 9.2mos.) & showed ORR of…

ByRidhi Rastogi4 days ago

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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 Rastogi5 days ago

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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

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The CHMP Recommends Immedica’s Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) to Treat 1L ES-SCLC

Shots: The CHMP has recommended Zepzelca + Tecentriq as a 1L therapy for adults with ES-SCLC whose disease remains stable after initial treatment with Tecentriq, carboplatin, & etoposide Opinion was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced risk of progression or death by 46% & death risk by 27% vs Tecentriq…

ByRidhi RastogiMarch 30, 2026

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Pharming Reports the CHMP Positive Opinion on Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta (APDS) Syndrome

Shots: The CHMP has recommended Joenja for the treatment of pts (≥12yrs.) with APDS syndrome, with EC decision expected in Q2’26, which, if positive, would be valid across all 30 EEA member states Opinion was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12 years), showing significant improvement in immune dysregulation…

ByRidhi RastogiMarch 30, 2026

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GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B

Shots: The EMA has accepted MAA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB) MAA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml across 29 countries Both trials met…

ByRidhi RastogiMarch 27, 2026

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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

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

Merck Receives the EC Approval for Keytruda, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for Gastrointestinal Stromal Tumors (GIST)

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

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

The CHMP Recommends Immedica’s Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) to Treat 1L ES-SCLC

Pharming Reports the CHMP Positive Opinion on Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta (APDS) Syndrome

GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B

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

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