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 NSCLCNDA 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) trialsThe ANCHOR-1 & ANCHOR-2 trial assessed Exdensur(Q6M)+ intranasal corticosteroids (SoC) vs PBO + SoC in 271 & 257 pts,…

ByRidhi RastogiApril 8, 2026

NEWS

Biocon Launches Bosaya and Aukelso (Biosimilar, Prolia & Xgeva) in the US

Shots:Biocon has reported the commercial launch of Bosaya & Aukelso, an interchangeable biosimilar version of Prolia & Xgeva (Denosumab) in the US, following FDA approval in Sep 2025 Bosaya will be available in the 60mg/mL PFS format, while Aukelso will be available as 120mg/1.7 mL (70mg/mL) single-dose vial, both for subcutaneous useDenosumab is a…

ByRidhi RastogiApril 8, 2026

NEWS

Endospan’s Nexus System Receives the US FDA Approval to Treat Aortic Arch Disease

Shots:The US FDA has approved the Nexus Aortic Arch Stent Graft for the treatment of aortic arch diseaseApproval was supported by the 1yr. results from the TRIOMPHE IDE trial assessing Nexus in aortic arch disease, incl. chronic aortic dissections, in pts at high risk for open surgical repair, which showed safe & effective treatment in…

ByRidhi RastogiApril 8, 2026

NEWS

Gilead to Acquire Tubulis for ~$5B

Shots:Gilead has entered into a definitive agreement to acquire Tubulis, making it an ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovationAs per the deal, Gilead will acquire Tubulis for $3.15B upfront & ~$1.85B in contingent milestone payments; closing is expected in Q2’26Acquisition will expand…

ByRidhi RastogiApril 8, 2026

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Biogen Collaborates with Alloy Therapeutics to Advance Antisense Therapeutics

Shots:Alloy Therapeutics has entered into a collaboration & license agreement with Biogen to advance antisense therapeutics against multiple undisclosed targets using Alloy’s AntiClastic ASO PlatformAs per the deal, Alloy will receive an upfront payment, along with additional milestone payments & tiered royalties on any products resulting from the collaborationThe AntiClastic ASO platform…

ByRidhi RastogiApril 7, 2026

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Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Shots:Akeso has reported P-Ib/II study data assessing cadonilimab + anlotinib & docetaxel in pts with locally advanced or metastatic NSCLC who progressed after prior PD-(L)1 inhibitor-based therapyAt mFU of 21.45mos., the trial showed 6mos. PFS rate of 55.7%, with an mPFS of 7mos. in the overall population, while in sq-NSCLC & PD-L1 TPS…

ByRidhi RastogiApril 7, 2026

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Organogenesis Reports Trial Results on PuraPly AM for Wound Healing in Diabetic Foot Ulcers

Shots:Organogenesis has reported the trial completion of PuraPly AM, assessing it in combination with SoC vs SOC alone for the management of non-healing diabetic foot ulcers (DFUs)The 170-patient trial achieved its 1EP, showing significant wound closure at 12wks., with the company planning to publish the study results soon in a journalPuraPly AM…

ByRidhi RastogiApril 7, 2026

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CuraTeQ Reports P-III Trial Data on BP11 (Biosimilar, Xolair) in Chronic Spontaneous Urticaria

Shots:CuraTeQ Biologics has reported topline P-III trial data assessing BP11, a biosimilar version of Xolair (omalizumab) vs Xolair in pts with chronic spontaneous urticariaTrial met its 1EPs in CSU at 300mg, evaluating ISS7 changes at Wk. 12 across 608 pts at ~80 sites, demonstrating equivalence between BP11 & Xolair within predefined marginsAdditionally,…

ByRidhi RastogiApril 7, 2026

NEWS

Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease

Shots:Amgen has reported topline P-III results assessing Tepezza (SC, Q2W × 12) vs PBO dosed via an on-body injector in pts with mod. to sev. active Thyroid Eye Disease (TED)The trial met its 1EP, showing a 76.7% vs 19.6% proptosis response rate, with 3.17 vs 0.80 mm mean proptosis reduction (key 2EP) at 24wks.…

ByRidhi RastogiApril 7, 2026

Ridhi Rastogi

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

Biocon Launches Bosaya and Aukelso (Biosimilar, Prolia & Xgeva) in the US

Endospan’s Nexus System Receives the US FDA Approval to Treat Aortic Arch Disease

Gilead to Acquire Tubulis for ~$5B

Biogen Collaborates with Alloy Therapeutics to Advance Antisense Therapeutics

Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Organogenesis Reports Trial Results on PuraPly AM for Wound Healing in Diabetic Foot Ulcers

CuraTeQ Reports P-III Trial Data on BP11 (Biosimilar, Xolair) in Chronic Spontaneous Urticaria

Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease

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