the US FDA | PharmaShots

AstraZeneca Reports the US FDA Acceptance of sBLA and Granted Priority Review for Imfinzi (durvalumab) to Treat Patients with Extensive-Stage Small Cell Lung Cancer

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

July 30, 2020July 30, 2020Shiwani Sharma

Shots: The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage [Read More...]

Insights+ Exclusive: The US FDA New Drug Approvals in June 2020

July 24, 2020July 24, 2020Shiwani Sharma

The US FDA has approved multiple NDAs and BLAs in Jun 2020, leading to treatments for patients and advances in the health care [Read More...]

Pfizer with its Partner BioNTech Receives the US FDA’s Fast Track Designation for Two mRNA Based Therapies to Treat COVID-19

July 13, 2020July 13, 2020Shiwani Sharma

Shots: The designation is based on preliminary data from P-I/II study assessing BNT162b1 including animal immunogenicity studies results that were released on Jul [Read More...]

Abbott Collaborates with Omada Health to Provide Integrated Digital Health and Coaching Experience for Patients with Type 2 Diabetes

Abbott’s Gallant ICD and CRT-D Devices Receives the US FDA’s Approval for Heart Rhythm Disorder with Bluetooth Connectivity

July 7, 2020July 7, 2020Shiwani Sharma

Shots: Abbott’s Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) are developed for heart rhythm disorders including patient-preferred design without compromising [Read More...]

Becton Dickinson Receives the US FDA’s EUA for its Third Point-Of-Care SARS-CoV-2 Diagnostic Test to Detect COVID-19

July 7, 2020July 13, 2020Shiwani Sharma

Shots: The US FDA has granted Emergency Use Authorization (EUA) for its rapid point-of-care BD Veritor SARS-CoV-2 Assay which allows the result in [Read More...]

Dermelix Collaborates with EspeRare to Co-develop and Commercialize DMX-101 for XLHED

EspeRare’s ER-004 Receives the US FDA’s Breakthrough Therapy Designation for Prenatal Treatment of XLHED

July 6, 2020July 6, 2020Shiwani Sharma

Shots: The BT designation is provided on three results from three XLHED subjects with a course of ER-004 intra-amniotic injections during the third [Read More...]

Evoke’s Gimoti (metoclopramide) Receives the US FDA’s Approval to Relief Symptoms in Adults with Acute and Recurrent Diabetic Gastroparesis

June 19, 2020July 22, 2020Shiwani Sharma

Shots: The US FDA’s approval allows Evoke to access its existing $5M line of credit from Eversana for manufacturing and commercialization of Gimoti [Read More...]

Pharma Mar’s Zepzelca (lurbinectedin) Receives the US FDA’s Accelerated Approval for Adult Patients with Metastatic Small Cell Lung Cancer (SCLC)

June 15, 2020July 22, 2020Shiwani Sharma

Shots: The approval is based on P-II assessing Zepzelca in 105 adults Ultragenyx with SCLC at 26 hospitals in the US and EU The [Read More...]

ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives MHLW’s Approval to Treat HIV 1 Infection

ViiV Healthcare’s Tivicay PD (dolutegravir) Receives the US FDA’s Approval for Children Living with HIV

June 12, 2020July 22, 2020Shiwani Sharma

Shots: The approval is based on ongoing P1093 (NCT03016533) and ODYSSEY (PENTA20, NCT02259127) studies in pediatric patients aged 4 weeks to 18 years, [Read More...]

Viela Bio’s Uplizna (inebilizumab-cdon) Receives the US FDA’s Approval to Treat Neuromyelitis Optica Spectrum Disorder (NMOSD)

June 11, 2020July 22, 2020Shiwani Sharma

Shots: The approval is based on N-MOmentum trial which involves assessing of Uplizna (300mg) vs placebo in 213 patients in the ratio (3:1) [Read More...]