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RedHill Biopharma's Second COVID-19 Candidate Cleared by FDA for Phase 2/3 Study americanpharmaceuticalreview
November 26, 2020
RedHill Biopharma announced the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for a Phase 2/3 study evaluating orally administered RHB-107 (upamostat) in patients with symptomatic COVID-19 ...
PLx Pharma Submits sNDAs for VAZALORE americanpharmaceuticalreview
November 26, 2020
PLx Pharma announced two chemistry and manufacturing control (CMC) supplemental New Drug Applications (sNDAs), one for VAZALORE 325 mg and one for VAZALORE 81 mg dose (referred to together as VAZALORE), have been submitted to the U.S. Food and Drug ...
Roche’s Xofluza gets FDA approval for influenza prevention pharmaceutical-technology
November 26, 2020
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Roche’s Xofluza (baloxavir marboxil) as a treatment to prevent influenza in people aged 12 years and above following post-exposure prophylaxis.
Lupin launches Tacrolimus Capsules USP expresspharma
November 26, 2020
They are indicated for the prophylaxis of organ rejection in combination with other immunosuppressants.
RhoVac's Prostate Cancer Drug Candidate, RV001, is granted Fast Track Designation by the FDA prnasia
November 25, 2020
RhoVac, a clinical stage company today announced that the American FDA has granted Fast Track Designation to the company's drug candidate, RV001.
FDA approves new dosing option for AZ’s Imfinzi pharmatimes
November 25, 2020
The US Food and Drug Administration (FDA) has approved AstraZeneca’s (AZ) checkpoint inhibitor Imfinzi for an additional dosing option.
Alembic Pharma JV, Aleor Dermaceuticals gets tentative nod from USFDA for Testosterone Gel expresspharma
November 25, 2020
It is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
ADC Therapeutics secures FDA priority review for Lonca in diffuse large B-cell lymphoma pharmaceutical-business-review
November 24, 2020
ADC Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and ...
Strides receives USFDA approval for Prednisone Tablets expresspharma
November 24, 2020
Prednisone is used as an anti-inflammatory or an immunosuppressant medication to treat different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.
Rilzabrutinib granted FDA fast track designation for treatment of immune thrombocytopenia pharmaceutical-business-review
November 23, 2020
The US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the oral investigational Bruton’s tyrosine kinase (BTK) inhibitor, rilzabrutinib, which has the potential to be the first BTK inhibitor for the treatment of immune ...

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