Bayer Reports the US FDA Approval of Ambelvist to Enhance MRI Detection of Lesions

Shots: The US FDA has approved Ambelvist (gadoquatrane) for contrast-enhanced MRI to detect lesions with abnormal vascularity in the CNS and other body regions in adults and pediatric patients, including term neonates Approval was supported by the global P-III (QUANTI) studies, which demonstrated that Ambelvist improved lesion visualization at a lower gadolinium dose (0.04 mmol Gd/kg) while providing diagnostic performance…

ByDipanshu DixitJune 12, 2026

NEWS

Genentech’s Tecentriq Receives the US FDA Priority Review for Stage III dMMR/MSI-H Colon Cancer

Shots: The US FDA has accepted sBLA & granted priority review to adj. Tecentriq (atezolizumab) & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) in combination with CT in stage III dMMR or MSI-H colon cancer (PDUFA: Oct 9, 2026) sBLA was based on the P-III (ATOMIC) trial assessing Tecentriq to FOLFOX6 CT in 712 pts with stage…

ByRidhi RastogiJune 11, 2026

NEWS

Organon Receives the US FDA Approval for the sBLA for Tofidence (Biosimilar, Actemra)

Shots: The US FDA has approved sBLA for Tofidence, a biosimilar version of Actemra (tocilizumab) Tofidence is an IL-6 receptor antagonist available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL single-dose vials for IV. The expanded approval adds indications for CAR T cell-induced severe or life-threatening cytokine release syndrome (CRS) and hospitalized adults and children (≥2 years) with COVID-19 requiring…

ByDipanshu DixitJune 10, 2026

NEWS

SpinaFX Receives the US FDA IDE Approval to Initiate Trial for Triojection Therapy

Shots: The US FDA has granted an IDE approval to Triojection therapy to initiate US trial in pts with contained herniated lumbar discs who have not responded to conservative therapy The trial is expected to enroll 300 pts across ~30 specialty spine centers, comparing intradiscal ozone/oxygen injection plus nerve root block against nerve root block…

ByRidhi RastogiJune 10, 2026

NEWS

Eli Lilly Receives the US FDA Approval for Ebglyss as a Q8W Maintenance Therapy for Atopic Dermatitis

Shots: The US FDA has approved Ebglyss (lebrikizumab-lbkz; 250mg/2mL, Q8W, SC) maintenance therapy for the treatment of pts (≥12yrs.; ≥40kg) with mod. to sev. atopic dermatitis Approval was supported by longitudinal exposure-response modeling & Q8W dosing data from an extension of the P-III (Adjoin) long-term trial, which assessed Ebglyss maintenance dosing for Q4W or Q8W over…

ByRidhi RastogiJune 10, 2026

INSIGHTS+

The US FDA New Drug Approvals in May 2026

Shots: The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases. Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP). Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…

ByDipanshu DixitJune 9, 2026

NEWS

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

NEWS

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

NEWS

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

NEWS

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

Bayer Reports the US FDA Approval of Ambelvist to Enhance MRI Detection of Lesions

Genentech’s Tecentriq Receives the US FDA Priority Review for Stage III dMMR/MSI-H Colon Cancer

Organon Receives the US FDA Approval for the sBLA for Tofidence (Biosimilar, Actemra)

SpinaFX Receives the US FDA IDE Approval to Initiate Trial for Triojection Therapy

Eli Lilly Receives the US FDA Approval for Ebglyss as a Q8W Maintenance Therapy for Atopic Dermatitis

The US FDA New Drug Approvals in May 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)

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