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Results For "ANDA"

2604 News Found

FDA Granted ODD to Utidelone Injectable from Biostar Pharma for treatment of breast cancer brain metastasis
Drug Approval | April 01, 2024

FDA Granted ODD to Utidelone Injectable from Biostar Pharma for treatment of breast cancer brain metastasis

Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux


Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data
Drug Approval | April 01, 2024

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024


NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
Drug Approval | March 30, 2024

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy


Tata Elxsi and Dräger collaborate to drive critical care innovation in India
Healthcare | March 28, 2024

Tata Elxsi and Dräger collaborate to drive critical care innovation in India

This partnership combines Tata Elxsi's design and technology expertise along with Dräger's expertise in medical and safety technology


lpca Laboratories enters into Technology Transfer Agreement with Omexa Formulary
News | March 28, 2024

lpca Laboratories enters into Technology Transfer Agreement with Omexa Formulary

Under this agreement, lpca will grant to Omexa a non-exclusive right to research, develop, manufacture and market an anti-cancer biosimilar for the global market


Caplin Group commences operations of Rs. 150 crore oncology facility
News | March 28, 2024

Caplin Group commences operations of Rs. 150 crore oncology facility

The facility will manufacture tablets, capsules, and injections for the oncology segment


Data privacy, security and ethical challenges must for adoption of GenAI in healthcare: PwC India
Digitisation | March 27, 2024

Data privacy, security and ethical challenges must for adoption of GenAI in healthcare: PwC India

The report underscores significant advancements in healthcare delivery, showcasing how GenAI facilitates improved diagnostic accuracy, operational efficiency and patient engagement


Apollo Cancer Centres heralds a new era in breast cancer surgery
Healthcare | March 27, 2024

Apollo Cancer Centres heralds a new era in breast cancer surgery

The surgeons were able to remove the entire breast while preserving the nipple through tiny hidden incisions


FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension
Drug Approval | March 27, 2024

FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension

WINREVAIR is a breakthrough biologic for this rare, progressive disease


AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer
Clinical Trials | March 23, 2024

AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer

Combination shows consistent benefit across prespecified post-progression outcomes