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DCGI approves Nintedanib for the treatment of systemic sclerosis-associated interstitial lung...

Being the first and only approved treatment option available for people living with SSc-ILD, the approval constitutes a breakthrough in an area of high unmet need. Following the FDA’s approval in September 2019, Nintedanib in SSc-ILD has so far been approved in 15 countries including the European Union, Canada, Japan and Brazil.................

First ‘Made in India’ COVID-19 tests kit by Mylab gets commercial...

Mylab is the first Indian company getting commercial COVID-19 PCR kit approved by CDSCO. The test kits cost nearly one-fourth of the currently procured kits and claim to reduce testing time by 65 percent............

Regulatory support, big pharma interest will boost precision medicine for cancer

The leading market analysis firm, GlobalData has predicted that the precision medicine approaches for for tumor agnostic development will accelerate due to the enhanced regulatory support and interest from big pharmaceutical players in the market...………..

Allogeneic stem cell therapy for peripheral artery disease raises hopes globally

Encouraging Phase II results were released in June 2018 for PLX-PAD, a placenta-based allogeneic stem cell therapy given intramuscularly, targeting peripheral artery disease (PAD)........................

US FDA approves Mylan & Biocon’s biosimilar, Fulphila

Second FDA-approved biosimilar through the Mylan-Biocon collaboration,, Fulphila is expected to be the first biosimilar pegfilgrastim available in the U.S. to help patients with nonmyeloid cancers reduce the risk of infection...............

Biocon & Mylan’s proposed biosimilar ‘Trastuzumab’ gets USFDA nod

The US-FDA Oncologic Drugs Advisory Committee has unanimously recommended approval of Mylan and Biocon’s proposed cancer targeting biosimilar, Trastuzumab.............

AstraZeneca gets DCGI’s approval for asthma drug, Symbicort 320

This fixed-dose combination drug approved by the Drug Controller General of India comprises budesonide and formoterol fumarate dehydrate and is delivered through a special device...........

CDSCO approves first autologous dendritic cell-based immuno-oncology product

APAC Biotech was granted with a commercial license by CDSCO to market its product, APCEDEN, a dendritic cell-based autologous immuno-oncology product for four cancer indications....

Strides Shasun receives USFDA tentative approval for Fingolimod capsules

On receiving full approval, the product will be manufactured at the company’s oral dosage facility at Bangalore and marketed by its subsidiary in USA, Strides Pharma Inc....

Haryana signs agreement with AiMED on investment worth Rs 5000 Cr...

The MoU was signed between the CM of Haryana Mr Manohar Lal Khattar and Mr Rajiv Nath, Forum Coordinator, AiMeD to enable ease of doing business, to attract investment for Haryana Medical devices industry....