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Results For "FDA"

1717 News Found

Takeda launches Adynovate for Hemophilia patients in India
News | May 16, 2022

Takeda launches Adynovate for Hemophilia patients in India

Adynovate in combination with Mypkfit offers personalized treatment and enables HCPs and patients to monitor factor levels from home and help achieve optimum QOL outcomes


Tirzepatide has potential to drive weight loss market dramatically, observes GlobalData
Biotech | May 15, 2022

Tirzepatide has potential to drive weight loss market dramatically, observes GlobalData

Tirzepatide is primarily indicated for the treatment of T2D and is expected to receive its decision from the FDA in Q2 2022


Neurocrine Biosciences receives Orphan Drug Designation for Valbenazine
Biotech | May 13, 2022

Neurocrine Biosciences receives Orphan Drug Designation for Valbenazine

The treatment of chorea associated with HD is within the scope of this Orphan Drug Designation


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