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Results For "approval"

2477 News Found

Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP
News | October 14, 2024

Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP

Wockhardt's yet another novel antibiotic Miqnaf receives favourable recommendation from Subject Expert Committee of CDSCO


AGC Biologics begins operations at new manufacturing building in Copenhagen
News | October 14, 2024

AGC Biologics begins operations at new manufacturing building in Copenhagen

The new facility uses the latest mammalian systems and single-use technology, including a production line with eight 2,000 L bioreactors


USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B
Drug Approval | October 12, 2024

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


OneSource unveils new brand identity at CPHI Milan
News | October 11, 2024

OneSource unveils new brand identity at CPHI Milan

Aims to achieve CDMO sales of US$ 400 million by 2028


Biocon Biologics’ sponsored report suggests ways to increase adoption of Biosimilars in poor countries
Policy | October 09, 2024

Biocon Biologics’ sponsored report suggests ways to increase adoption of Biosimilars in poor countries

Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines


Briefs: Aurobindo Pharma and Lupin
News | October 06, 2024

Briefs: Aurobindo Pharma and Lupin

USFDA completes PAI of Lupin’s biotech facility in Pune


Venus Remedies secures marketing authorisations for key oncology drugs from Morocco
News | October 01, 2024

Venus Remedies secures marketing authorisations for key oncology drugs from Morocco

The authorization of bortezomib will enhance the company’s ability to deliver advanced cancer solutions in Southeast Asia


Amcor's long-term SBTi targets confirmed
Sustainability | September 28, 2024

Amcor's long-term SBTi targets confirmed

The net-zero target approval complements the company's near-term emission reduction targets


AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin
Drug Approval | September 28, 2024

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin

Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression