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Results For "USFDA"

1130 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


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


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


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


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


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


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


Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer
Biotech | April 27, 2022

Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers