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Results For "FDA"

2194 News Found

First patient dosed with antiepileptic drug candidate CB03 in a first-in-human Phase I trial
Biotech | May 12, 2022

First patient dosed with antiepileptic drug candidate CB03 in a first-in-human Phase I trial

CB03 is a candidate drug for the treatment of refractory epilepsy, independently developed by Zhimeng


Suven Pharmaceuticals - CDMO core growth intact; formulations to pick up
News | May 12, 2022

Suven Pharmaceuticals - CDMO core growth intact; formulations to pick up

Anand Rathi maintains long-term guidance of 10-15% revenue growth and 40% EBITDA margins


Ascletis announces U.S. IND approval of ASC22 for HIV patients
Biotech | May 11, 2022

Ascletis announces U.S. IND approval of ASC22 for HIV patients

ASC22 (Envafolimab) is a subcutaneously administered single-domain antibody against PD-L1 and has the potential to restore virus-specific immune responses in patients with chronic viral infection


Aarti Drugs Q4FY 22 consolidated revenue grew by 39 per cent YoY
News | May 10, 2022

Aarti Drugs Q4FY 22 consolidated revenue grew by 39 per cent YoY

The capex for FY22 stood at Rs 145 crore and is expected to be in the range of Rs 250-350 crore for the entire FY23 which would be funded through a mix of internal accruals and debt


Glenmark receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate
Drug Approval | May 09, 2022

Glenmark receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate

Glenmark's current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 ANDA's pending approval with the USFDA


InxMed raises US $ 15 million in Series B+ financing
Startup | May 09, 2022

InxMed raises US $ 15 million in Series B+ financing

The plan is to advance innovative therapies to drug-resistant cancers


Juniper Biologics signs exclusive license agreement with Helsinn for infigratinib (INN) for the emerging markets including India
Biotech | May 04, 2022

Juniper Biologics signs exclusive license agreement with Helsinn for infigratinib (INN) for the emerging markets including India

Infigratinib is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any other indication


Gland launches Bortezomib in the US market
Drug Approval | May 04, 2022

Gland launches Bortezomib in the US market

Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma


Xcardia announces first-in-human use of its new Xtractor device
Biotech | May 02, 2022

Xcardia announces first-in-human use of its new Xtractor device

The announcement follows FDA 510(k) clearance of device


Sona Group partners with Mycelium Biotechnology for R&D in Salem
Biotech | May 02, 2022

Sona Group partners with Mycelium Biotechnology for R&D in Salem

As a global mushroom biotechnology group, Mycelium Biotechnology is engaged in mushroom growing, global distribution and offering biotechnology and nutraceutical solutions through global partners