Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment

US FDA approval based on NEURO-TTRansform Phase III results

Pfizer bags rull FDA nod for BRAFTOVI combination in aggressive colorectal cancer

BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results

MHRA warns of extremely rare vision risk linked to semaglutide

Semaglutide—a glucagon?like peptide?1 receptor agonist (GLP-1RA) sold as Ozempic and Rybelsus for type 2 diabetes, and Wegovy for weight management and cardiovascular risk reduction

FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer

Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells

Sanofi flags delay in FDA review of Tolebrutinib for progressive multiple sclerosis

MIRA Pharmaceuticals advances oral Ketamir-2 into Phase 1 MAD study for chemotherapy-induced neuropathic pain

Advancing toward Phase 2a evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track designation

Asahi Kasei Pharma starts Phase III study of promising CIPN prevention therapy

ART-123 is a recombinant human thrombomodulin approved in Japan in 2008

Alkem enters into licensing agreement with BioTherapeutics

Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings

Strides receives USFDA approval for Gabapentin Tablets

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty

USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer

Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy