Xenix Medical Reports the US FDA Clearance for Lux Expandable Lumbar Fusion System

Shots: Xenix Medical has received the US FDA 510(k) clearance & initiated the full commercial launch of its Lux Expandable Lumbar Interbody Fusion System Lux features up to 4.5mm of controlled post-implant expansion, enables bone graft delivery through the inserter into a large endplate-to-endplate graft window after expansion, & incorporates NanoACTIV surface tech. to support fusion…

ByRidhi RastogiJune 9, 2026

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Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

Shots: The US FDA has approved Pfizer's Hympavzi for the treatment of pts (≥12yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B with or without inhibitors Approval of Hympavzi (SC, QW) in pts (≥12yrs.) was supported by the P-III (BASIS) trial, showing improved key bleeding outcomes incl.…

ByRidhi RastogiJune 9, 2026

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GSK to Acquire Nuvalent for ~$10.6B

Shots: GSK has entered an agreement to acquire Nuvalent, accelerating its entry into lung cancer As per the deal, GSK will acquire Nuvalent through a tender offer of $124 per share in cash, valuing the company at ~$10.6B (£8.0B); net of acquired cash, GSK’s total investment is estimated at $9.4B (£7.1B). Closing is expected in…

ByRidhi RastogiJune 9, 2026

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Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Shots: The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev. active ulcerative colitis & Crohn’s disease BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity between AVT16 & the reference product, plus Alvotech has filed a…

ByRidhi RastogiJune 8, 2026

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Lupin Receives US FDA Approval for Ranluspec (Biosimilar, Lucentis)

Shots: The US FDA has approved Ranluspec (ranibizumab-hkdz), a biosimilar version of Lucentis (ranibizumab) Ranluspec is an interchangeable ranibizumab biosimilar approved in the US, available in both vials and PFS at 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL) strengths, matching Lucentis It is a recombinant humanized IgG1 mAb fragment that inhibits VEGF-A and is indicated for wet age-related macular degeneration,…

ByDipanshu DixitJune 5, 2026

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Xbrane Reports the US FDA Acceptance of Resubmitted BLA for Lucamzi (Biosimilar, Lucentis)

Shots: The US FDA has accepted the resubmitted BLA for Xbrane's Lucamzi, a biosimilar to Lucentis, & assigned a BsUFA action date of Oct 29, 2026 The resubmission, completed in Apr 2026, addressed issues identified in the CRL received from the FDA in Oct 2025 The product is already approved & marketed in EU as…

ByRidhi RastogiJune 4, 2026

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Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

Shots: The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept) Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems…

ByRidhi RastogiJune 4, 2026

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Genentech Receives the US FDA Priority Review for Giredestrant as an Adjuvant Treatment of ER+ Early-Stage Breast Cancer

Shots: The US FDA has accepted NDA & granted priority review to Genentech’s giredestrant as an adj. treatment for adults with ER+, HER2-, ESR1-mutated stage I, II, and III breast cancer (PDUFA: Nov 30, 2026) NDA was supported by the P-III (lidERA Breast Cancer) trial (n>4,100), where adj. giredestrant reduced iDFS by 30%, with 92.4%…

ByRidhi RastogiJune 2, 2026

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NeuroPace Receives the US FDA Approval for ECoG Assistant to Advance AI-Driven Epilepsy Care

Shots: The US FDA has approved ECoG Assistant, an AI-powered clinician tool designed to support epilepsy management using data from the RNS System, with NeuroPace debuting the tool at ASSFN’26 ECoG Assistant was developed using 124,450 epileptologist-labeled intracranial EEG records & identifies ECoGs of Interest, enabling clinicians to review long-term EEG trends & circadian activity…

ByRidhi RastogiJune 1, 2026

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Merck Secures the US FDA Breakthrough Therapy Designation for Calderasib to Treat Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC

Shots: The US FDA has granted BTD to Merck's calderasib (MK-1084) + Keytrudafor the 1L treatment of pts with advanced or metastatic NSCLC with KRAS G12C-mutation & expressing PD-L1 (TPS ≥1%) Designation was supported by P-I (KANDLELIT-001) trial data showing calderasib monotx. (n=21) achieved a 38% ORR, calderasib + Keytruda (n=69) delivered an ORR of 77%, while…

ByRidhi RastogiMay 29, 2026

Xenix Medical Reports the US FDA Clearance for Lux Expandable Lumbar Fusion System

Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

GSK to Acquire Nuvalent for ~$10.6B

Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Lupin Receives US FDA Approval for Ranluspec (Biosimilar, Lucentis)

Xbrane Reports the US FDA Acceptance of Resubmitted BLA for Lucamzi (Biosimilar, Lucentis)

Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

Genentech Receives the US FDA Priority Review for Giredestrant as an Adjuvant Treatment of ER+ Early-Stage Breast Cancer

NeuroPace Receives the US FDA Approval for ECoG Assistant to Advance AI-Driven Epilepsy Care

Merck Secures the US FDA Breakthrough Therapy Designation for Calderasib to Treat Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC

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