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Results For "approval"

2477 News Found

Moderna wins EU backing for world’s first combined flu-COVID shot
News | March 02, 2026

Moderna wins EU backing for world’s first combined flu-COVID shot

The decision marks a pivotal moment for the Massachusetts-based biotech giant


Zydus hits Keytruda biosimilar milestone with successful FYB206 trial, targets USFDA filing
News | February 28, 2026

Zydus hits Keytruda biosimilar milestone with successful FYB206 trial, targets USFDA filing

Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets


Lupin’s Vinita Gupta honoured as CNBC Changemaker for revolutionising U.S. healthcare access
People | February 28, 2026

Lupin’s Vinita Gupta honoured as CNBC Changemaker for revolutionising U.S. healthcare access

Vinita has made expansion in the U.S. a core pillar of Lupin’s worldwide growth strategy


Merck’s KEYTRUDA shows significant survival boost in platinum-resistant ovarian cancer
Clinical Trials | February 28, 2026

Merck’s KEYTRUDA shows significant survival boost in platinum-resistant ovarian cancer

KEYTRUDA had previously met its primary endpoint of progression-free survival in all patients


Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe
News | February 28, 2026

Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe

AA, a chronic immune disease, can cause extensive and unpredictable hair loss


FDA nod to Boehringer Ingelheim’s first-line therapy for HER2-mutant lung cancer
Drug Approval | February 28, 2026

FDA nod to Boehringer Ingelheim’s first-line therapy for HER2-mutant lung cancer

Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy


Pfizer bags rull FDA nod for BRAFTOVI combination in aggressive colorectal cancer
Drug Approval | February 27, 2026

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


Genprex bags major patent wins in Japan & Europe for REQORSA cancer therapy
R&D | February 26, 2026

Genprex bags major patent wins in Japan & Europe for REQORSA cancer therapy

The Japanese Patent Office has issued a favorable Appeal Decision granting a patent for the use of REQORSA Gene Therapy in combination with PD-L1 antibodies to treat cancer


Envoy Medical secures three new patents, bolstering cochlear implant leadership
News | February 26, 2026

Envoy Medical secures three new patents, bolstering cochlear implant leadership

The new patents cover critical advancements in cochlear implant technology


CStone Pharmaceuticals’ Sugemalimab bags UK nods for Stage III NSCLC
Clinical Trials | February 25, 2026

CStone Pharmaceuticals’ Sugemalimab bags UK nods for Stage III NSCLC

Sugemalimab, developed using CStone’s OmniRat transgenic platform, is a fully human IgG4 monoclonal antibody designed to minimize immunogenicity and toxicity