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Results For "FDA"

2190 News Found

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


NORD announces over US $ 100,000 in grant funding available for rare disease research
Biotech | May 02, 2022

NORD announces over US $ 100,000 in grant funding available for rare disease research

Three RFPs now open for qualified researchers through NORD's Jayne Holtzer rare disease research grants program


Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone
Biotech | May 02, 2022

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone

The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023


India’s pharma exports grow by 103% since 2013-14
News | May 01, 2022

India’s pharma exports grow by 103% since 2013-14

Pharma exports in 2021-22 sustain a positive growth despite global trade disruptions


Ultomiris approved in the US for adults with generalised myasthenia gravis
Drug Approval | April 29, 2022

Ultomiris approved in the US for adults with generalised myasthenia gravis

Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks