approval Archives | PharmaShots

Pfizer’s Fragmin (dalteparin sodium) Receives FDA’s Approval for Symptomatic Venous Thromboembolism in Pediatric Patients

May 17, 2019May 17, 2019Tuba Khan

Shots: The approval is based on the single study results assessing Fragmin (dalteparin sodium) in 38 pediatric patients with symptomatic deep vein thrombosis [...]

Roche and AbbVie’s Venclexta (venetoclax) + Gazyva (obinutuzumab) Receive FDA’s Approval for Untreated Chronic Lymphocytic Leukemia

May 16, 2019May 17, 2019Tuba Khan

Shots: The approval is based on the P-III CLL14 study results assessing Venclexta + Gazyva vs Gazyva + chlorambucil in 432 patients with [...]

Merck KGaA and Pfizer’s Bavencio (avelumab) + Inlyta (axitinib) Receive FDA’s Approval as 1L Treatment for Advanced Renal Cell Carcinoma

May 15, 2019May 16, 2019Tuba Khan

Shots: The approval is based on P-III JAVELIN Renal 101 study (NCT02684006) results assessing bavencio (avelumab) + Inlyta (axitinib) vs sunitinib in 886 [...]

Regeneron’s Eylea (aflibercept) Injection Receives FDA’s Approval for Diabetic Retinopathy

May 14, 2019May 15, 2019Tuba Khan

Shots: The approval is based on P-III PANORAMA study results assessing Eylea (q8w, q16w) vs sham in 402 patients with non-proliferative diabetic retinopathy [...]

Eli Lilly’s Cyramza (ramucirumab) Receives FDA’s Approval as a Second-line Treatment in Patients with High AFP Hepatocellular Carcinoma

May 13, 2019May 15, 2019Tuba Khan

Shots: The approval is based on REACH‑2 study (NCT02435433) results assessing Cyramza (ramucirumab) + BSC vs PBO + BSC in 292 advanced HCC [...]

Sanofi’s Dupixent (dupilumab) Receives European Commission Approval for Severe Asthma with Type 2 Inflammation

May 8, 2019May 10, 2019Tuba Khan

Shots: The approval is based on LIBERTY ASTHMA program including two P-III (QUEST and VENTURE) & one P-IIb studies assessing Dupixent + SOC [...]

BioMarin’s Palynziq (pegvaliase injection) Receives European Commission’s MAA Approval for Phenylketonuria

May 7, 2019May 10, 2019Tuba Khan

Shots: The approval is based on P-III PRISM-2 study results assessing Palynziq (pegvaliase injection, 20 & 40 mg) vs PBO in 215 PKU [...]

Pfizer’s Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) Receive FDA’s Approval for Transthyretin Amyloid Cardiomyopathy

May 6, 2019May 8, 2019Tuba Khan

Shots: The approval is based on P-III ATTR-ACT study assessing Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) vs PBO in patients with ATTR-CM The [...]

Roche’s Kadcyla (trastuzumab emtansine) Receives FDA’s Expanded Approval as an Adjuvant Treatment for HER2+ Early Breast Cancer in the US

May 6, 2019May 8, 2019Tuba Khan

Shots: The approval is based on P-III KATHERINE study results assessing Kadcyla versus Herceptin in patients with HER2+ early breast cancer (eBC) with [...]

AstraZeneca’s Qternmet XR (dapagliflozin, saxagliptin, metformin hydrochloride) Receives FDA’s Approval for Type-2 Diabetes in the US

May 3, 2019May 7, 2019Tuba Khan

Shots: The approval is based on two P-III studies assessing the combination of dapagliflozin (5mg, 10mg) ,saxagliptin (5mg) and metformin in patients with [...]