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Results For "regulatory"

1227 News Found

AstraZeneca receives CDSCO approval for Tremelimumab combination in India
Drug Approval | June 02, 2023

AstraZeneca receives CDSCO approval for Tremelimumab combination in India

Tremelimumab in combination with Durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC)


Capnopharm receives CE certification for its new CapnoPen technology
News | May 31, 2023

Capnopharm receives CE certification for its new CapnoPen technology

Capnopharm’s new CapnoPen is the first PIPAC nebulizer to obtain CE marking under the new MDR regulation 2017/745


Hikal posts FY23 PAT at Rs. 36 Cr
News | May 30, 2023

Hikal posts FY23 PAT at Rs. 36 Cr

Pharmaceutical sales was flat and stood at Rs. 309 crore as compared to Rs. 308 crore in Q4 FY22


We need to focus on quality and affordable manufacturing: Mandaviya
Policy | May 29, 2023

We need to focus on quality and affordable manufacturing: Mandaviya

Dr. Mandaviya urged the stakeholders to capitalize on the current opportunities


Roquette, Beren Therapeutics join forces to advance cyclodextrin technologies
News | May 29, 2023

Roquette, Beren Therapeutics join forces to advance cyclodextrin technologies

Aim of the agreement is to expand the full potential of Beren’s cyclodextrin technologies and their medicinal applications.


Lonza launches TheraPEAK T-VIVO cell culture medium to accelerate cell therapy development
News | May 24, 2023

Lonza launches TheraPEAK T-VIVO cell culture medium to accelerate cell therapy development

Lonza launches the TheraPEAK T-VIVO Cell Culture Medium with a novel chemically defined formulation developed to optimize and streamline CAR T-cell manufacturing


Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection
Drug Approval | May 23, 2023

Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection

This is the second US FDA GMP inspection of this facility within one year


Hikal announces USFDA audit with zero observations
Drug Approval | May 16, 2023

Hikal announces USFDA audit with zero observations

This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites


USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’
Drug Approval | May 12, 2023

USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time


Venus Remedies bolsters its position in oncology space with marketing approval from Philippines, Iraq
Drug Approval | May 10, 2023

Venus Remedies bolsters its position in oncology space with marketing approval from Philippines, Iraq

The company moves a step closer towards achieving its goal of emerging as the top oncology medicine supplier from India in the ASEAN region