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Shilpa Medicare gets US FDA tentative nod for Apremilast Tablets expresspharma
March 05, 2021
Shilpa Medicare has received US Food and Drug Administration (US FDA) tentative approval for its ANDA, Apremilast Tablets, 10 mg, 20 mg, and 30 mg dated 04 Mar 2021.
Unichem Labs gets USFDA approval for Guanfacine Tablets expresspharma
March 05, 2021
Unichem Laboratories has received ANDA approval for its Guanfacine Tablets, USP 1 mg and 2 mg from the United States Food and Drug Administration (USFDA) to market a generic version of TENEX (Guanfacine) Tablets 1 mg and 2 mg of Promius Pharma.
CMAB Biopharma Congratulates Partner Innovent Biologics on FDA Clearance of IND Application of its COVID-19 Antibody Project prnasia
March 04, 2021
CMAB Biopharma (Suzhou) Inc. congratulates its partner Innovent Biologics, Inc. on the U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for its antibody candidate which targets the COVID-19 virus ...
FDA Authorizes Quidel QuickVue At-Home COVID-19 Test americanpharmaceuticalreview
March 04, 2021
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without ...
FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine americanpharmaceuticalreview
March 04, 2021
The U.S. Food and Drug Administration (FDA) announced it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up ...
Agios Submits sNDA for TIBSOVO for IDH1-Mutant Cholangiocarcinoma americanpharmaceuticalreview
March 04, 2021
Agios Pharmaceuticals has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for TIBSOVO® (ivosidenib tablets) as a potential treatment for patients with previously treated isocitrate dehydrogenase 1 ...
PLx Pharma Receives FDA Approval of SNDAs for Two VAZALORE Dosages americanpharmaceuticalreview
March 04, 2021
PLx Pharma announced the U.S. Food and Drug Administration (FDA) approved supplemental new drug applications (sNDAs) for its lead products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as VAZALORE), the first novel, liquid-filled aspirin ...
Aleor Dermaceuticals gets USFDA Final nod for Testosterone Gel expresspharma
March 04, 2021
Testosterone Gel is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Pfizer gets full US FDA nod for LORBRENA as first-line treatment for ALK-Positive metastatic NSCLC expresspharma
March 04, 2021
Approval is based on CROWN trial, which showed a 72 per cent reduction in risk of progression or death for treatment with LORBRENA vs. XALKORI.
B. Braun Receives FDA Approval for Acetaminophen Injection in Multiple Doses americanpharmaceuticalreview
March 03, 2021
B. Braun Medical have received approval from the U.S. Food & Drug Administration (FDA) for the first and only Acetaminophen Injection available in multiple doses.

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