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Results For "approval"

2612 News Found

Revolutionary wearable ultrasound device gains USFDA approval
Healthcare | May 27, 2022

Revolutionary wearable ultrasound device gains USFDA approval

Manamed, a pioneering Medical Technology development company, has been granted FDA approval on its latest orthopaedic recovery device, ManaSport.


Eugia Pharma receives USFDA approval for Pemetrexed
Drug Approval | May 26, 2022

Eugia Pharma receives USFDA approval for Pemetrexed

Pemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)


Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection
Drug Approval | May 26, 2022

Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection

Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)


Borrena approval strengthens Pfizer position in China NSCLC market: GlobalData
News | May 25, 2022

Borrena approval strengthens Pfizer position in China NSCLC market: GlobalData

According to GlobalData’s ‘Pharmaceutical Intelligence Center’, the number of diagnosed prevalent cases of ALK-mutant NSCLC in China is estimated to grow at a CAGR of 5.3% from 22,725 in 2021 to 31,902 in 2029


Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets
Drug Approval | May 24, 2022

Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets

The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA


CHMP recommends European Commission approval of Rinvoq
Drug Approval | May 23, 2022

CHMP recommends European Commission approval of Rinvoq

Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients


Glenmark receives sANDA approval for Abiraterone Acetate tablets
Drug Approval | May 20, 2022

Glenmark receives sANDA approval for Abiraterone Acetate tablets

According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million


Don’t be left short-changed post approval – plan in change orders early for accelerated pathways: Stephanie Gaulding
News | May 19, 2022

Don’t be left short-changed post approval – plan in change orders early for accelerated pathways: Stephanie Gaulding

A post approval change order is often necessary, but innovators should plan and prepare for this pre-approval. Planning alongside outsourcing partners will help ensure that only a small-scale study is needed—not a new full clinical study


Themis Medicare gets add on approval for Viralex
Drug Approval | May 18, 2022

Themis Medicare gets add on approval for Viralex

Viralex (Inosine Pranobex) is an immunomodulatory agent with broad-spectrum antiviral properties


University of Nebraska Medical Center and ANANDA Scientific announce USFDA approval
Biotech | May 17, 2022

University of Nebraska Medical Center and ANANDA Scientific announce USFDA approval

The study will evaluate the effectiveness of Nantheia ATL5, an investigational drug using cannabidiol in ANANDA’s proprietary delivery technology