Adults | PharmaShots

MHLW Expedites the Reviews of Gilead’s Remdesivir to Treat Patients with COVID-19 in Japan

Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

July 13, 2020July 13, 2020Shiwani Sharma

Shots: The TGA authorization follows the recent data shared by EMA and Singapore Health Sciences Authority for remdesivir’s approval in EU, Singapore and, [Read More...]

LEO Reports the US FDA’s Acceptance of BLA for Tralokinumab to Treat Adults with Moderate to Severe Atopic Dermatitis

July 10, 2020July 10, 2020Tuba Khan

Shots: The BLA submission is based on P-III ECZTRA 1 & 2 studies assessing tralokinumab (300mg, SC) as monothx. vs PBO in 804 [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...]

Mallinckrodt Signs an Agreement with Silence Therapeutics to Develop and Commercialize RNAi Therapeutics for Complement-Mediated Diseases

Mallinckrodt Reports Completion of BLA Submission to the US FDA for StrataGraft to Treat Deep Partial-Thickness Thermal Burns in Adults

June 9, 2020June 9, 2020Shiwani Sharma

Shots: In Apr 2020, Mallinckrodt’s Stratatech initiated StrataGraft’s BLA submission process which is a regenerative skin tissue therapy to develop therapies for deep [Read More...]

Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for adults with Relapsed and Refractory Multiple Myeloma

June 2, 2020June 5, 2020Tuba Khan

Shots: EC’s approval is based on P-III ICARIA-MM study assessing Sarclisa + (pomalidomide and dexamethasone) pom-dex vs pom-dex as monothx. for patients with [Read More...]

Dr. Reddy's Laboratories Launches Versavo (biosimilar, bevacizumab) for Multiple Cancers in India

Dr. Reddy’s Elyxyb (celecoxib oral solution) Receives the US FDA’s Approval for Acute Treatment of Migraine with or Without Aura in Adults

May 6, 2020June 18, 2020Shiwani Sharma

Shots: ELYXYB (previously as DFN-15) is an oral solution formulated using a self-micro emulsifying drug delivery system helps in improving solubility and bioavailability [Read More...]

Janssen Collaborates with BARDA to Facilitate the Development of Corona Virus Vaccine

Genmab and Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receive the US FDA’s Approval to Treat Multiple Myeloma in Adults

May 1, 2020June 18, 2020Shiwani Sharma

Shots: The approval is based on two studies: COLUMBA (MMY3012, P-III) study and P-II PLEIADES (MMY2040) study, which involves assessing of subcutaneous daratumumab [Read More...]

Incyte Reports Updated Results of Pemigatinib in P-II FIGHT-202 Trial for Patients with Previously Treated Advanced Cholangiocarcinoma

Incyte’s Pemazyre (pemigatinib) Receives the US FDA’s Approval as the Novel Treatment for Adults with Previously Treated, Unresectable LA or Metastatic Cholangiocarcinoma

April 17, 2020May 15, 2020Shiwani Sharma

Shots: The approval is based on P-II FIGHT-202 (NCT02924376) study which involves assessing of Pemazyre (13.5 mg, qd) in adults with previously treated, [Read More...]

Astellas Reports Results of Mirabegron in P-IV PLUS Study to Reduce Overactive Bladder Symptoms in Men

Astellas Reports NMPA’s Acceptance of NDA for XOSPATA (gilteritinib) to Treat R/R AML with a FLT3 Mutation in Adults

April 10, 2020April 10, 2020Shiwani Sharma

Shots: Gilteritinib is a FMS-like tyrosine kinase 3 (FLT3) and has inhibitory activity against FLT3-ITD which is a type of FLT3mut+ found in [Read More...]