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Results For "USFDA"

1453 News Found

FDA greenlights AstraZeneca’s Imfinzi combo in bladder cancer breakthrough
R&D | May 30, 2026

FDA greenlights AstraZeneca’s Imfinzi combo in bladder cancer breakthrough

The study tracked patients for more than five years (median 60.7 months), with protection against disease returning emerging in under four months and continuing long term


Lupin secures FDA nod for generic Sutab tablets with 180-day exclusivity
Drug Approval | May 30, 2026

Lupin secures FDA nod for generic Sutab tablets with 180-day exclusivity

The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals


AbbVie wins FDA nod for DECNUPAZ in rare blood cancer
News | May 29, 2026

AbbVie wins FDA nod for DECNUPAZ in rare blood cancer

BPDCN typically presents with skin lesions before rapidly spreading to the bone marrow, lymph nodes


Hikal swings back to profit in Q4 FY26 despite regulatory hit & strategic charges
News | May 28, 2026

Hikal swings back to profit in Q4 FY26 despite regulatory hit & strategic charges

Hikal’s Q4 profit remained sharply lower year-on-year, falling 71% from Rs. 50.2 crore in Q4 FY25 as the company absorbed regulatory pressures and strategic accounting adjustments


Lupin’s Ankleshwar facility receives EIR from U.S. FDA
Drug Approval | May 28, 2026

Lupin’s Ankleshwar facility receives EIR from U.S. FDA

The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026


Morepen Labs posts strong Q4 FY26 net profit
News | May 28, 2026

Morepen Labs posts strong Q4 FY26 net profit

For the full year, standalone gross revenue crossed Rs. 1,700 crore


Datroway wins US nod in aggressive breast cancer subtype
Drug Approval | May 25, 2026

Datroway wins US nod in aggressive breast cancer subtype

Clearance marks major shift beyond chemotherapy


Reliance Life Sciences appoints Siva Sankar Mahamkali as VP Biosimilars Manufacturing Operations
People | May 22, 2026

Reliance Life Sciences appoints Siva Sankar Mahamkali as VP Biosimilars Manufacturing Operations

Biologics manufacturing veteran brings over two decades of expertise in biosimilars, GMP operations, and large-scale biopharmaceutical manufacturing


Aurobindo Pharma Q4 FY26 revenue rises 5.6% to Rs. 8,853 crore
News | May 22, 2026

Aurobindo Pharma Q4 FY26 revenue rises 5.6% to Rs. 8,853 crore

Net profit stood at Rs. 921 crore for the quarter, while Europe revenues surged 30.2% YoY to Rs. 2,795 crore


Shaily gets regulatory nod for launch of ShailyPen Neo device technology
Medical Device | May 20, 2026

Shaily gets regulatory nod for launch of ShailyPen Neo device technology

The product has received tentative USFDA approval, Health Canada notice of compliance, and Indian regulatory approval