Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early

Shots: The US FDA has granted clearance to ECG-AI algorithm, a software-as-a-medical-device designed for cardiac amyloidosis (CA), cleared for use with standard 12-lead ECGs ECG-AI algorithm analyzes ECG waveforms to detect CA-related patterns not visible to clinicians, integrating into existing workflows using routine ECGs without additional testing to help identify at-risk pts & guide next…

ByRidhi RastogiApril 9, 2026

NEWS

Halozyme Licenses Hypercon Technology to Vertex for Convenient Drug Delivery

Shots: Halozyme Therapeutics, via its subsidiary Halozyme Hypercon, has entered a global exclusive collaboration & license agreement with Vertex to utilize its Hypercon technology across up to three drug targets As per the deal, Halozyme will receive $15M upfront, with additional milestone payments & royalties tied to products developed using the technology Hypercon is a…

ByRidhi RastogiApril 8, 2026

NEWS

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

NEWS

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

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 use Denosumab 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 disease Approval 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 innovation As per the deal, Gilead will acquire Tubulis for $3.15B upfront & ~$1.85B in contingent milestone payments; closing is expected in Q2’26 Acquisition will expand…

ByRidhi RastogiApril 8, 2026

NEWS

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 Platform As per the deal, Alloy will receive an upfront payment, along with additional milestone payments & tiered royalties on any products resulting from the collaboration The AntiClastic ASO platform…

ByRidhi RastogiApril 7, 2026

NEWS

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 therapy At 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

NEWS

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 journal PuraPly AM…

ByRidhi RastogiApril 7, 2026

Ridhi Rastogi

Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early

Halozyme Licenses Hypercon Technology to Vertex for Convenient Drug Delivery

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

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