Insights+: EMA Marketing Authorization of New Drugs in April 2024

Shots: The EC approved 10 New Chemical Entities in April 2024, leading to treatments for patients and advances in the healthcare industry In April 2024, the major highlighted drugs were Takeda’s Fruzaqla to treat Adults with mCRC and Johnson & Johnson’s Rybrevant for the treatment NSCLC PharmaShots has compiled a list of 5 drugs that have received positive…

ByDipanshu DixitMay 21, 2024

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Insights+: EMA Marketing Authorization of New Drugs in March 2024

Shots: The EC approved 1 Biologic and 11 New Chemical Entities in March 2024, leading to treatments for patients and advances in the healthcare industry In March 2024, the major highlighted drugs were Novartis’ Fabhalta to treat PNH and UCB’s Bimzelx for the treatment of Adults with Moderate to Severe Hidradenitis Suppurativa PharmaShots has compiled…

ByDipanshu DixitApril 22, 2024

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Insights+: EMA Marketing Authorization of New Drugs in January 2024

Shots:The EMA approved 2 BLA and 6 New Chemical Entities in January 2024, leading to treatments for patients and advances in the healthcare industryIn January 2024, the major highlighted drugs were Padcev to treat Bladder Cancer and Eylea for the treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)PharmaShots has…

BySenior EditorFebruary 21, 2024

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Julie Blaedel from Genmab and Michael Moran from AbbVie Discuss the Conditional EC Approval of TEPKINLY in a Stimulating Conversation with PharmaShots

Shots: Diffuse large B-cell lymphoma remains the most common type of non-Hodgkin lymphoma. With limited therapeutic options for patients whose disease gets relapsed or refractory, AbbVie and Genmab’s TEPKINLY is one-of-a-kind monotherapy for adult patients with relapsed or refractory DLBCL Post EC’s conditional approval, Julie Blaedel & Michael Moran engage in an enlightening conversation with…

BySaurabh ChaubeyJanuary 10, 2024

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Insights+: EMA Marketing Authorization of New Drugs in October 2023

Shots:The EMA approved 2 BLA while 7 new chemical Entity, 6 BLA received positive CHMP opinion in October 2023, leading to treatments for patients and advances in the healthcare industryIn October 2023, the major highlight drugs were Keytruda + trastuzumab 1L treatment of LA unresectable or metastatic HER2+ gastric or GEJ adenocarcinoma &…

BySenior EditorNovember 23, 2023

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Insights+: EMA Marketing Authorization of New Drugs in September 2023

Shots: The EMA approved 11 New Chemical Entity (NCE) and 8 Biologic Drugs in September 2023, leading to treatments for patients and advances in the healthcare industry In September 2023, the major highlight drugs were Litfulo (ritlecitinib) for adolescents and adults with s9ere alopecia areata & Orserdu (elacestrant) for ER+, HER2- locally advanced or metastatic…

BySenior EditorOctober 26, 2023

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New Drug Designations – August 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…

BySenior EditorSeptember 18, 2023

Insights+: EMA Marketing Authorization of New Drugs in April 2024

Insights+: EMA Marketing Authorization of New Drugs in March 2024

Insights+: EMA Marketing Authorization of New Drugs in January 2024

Julie Blaedel from Genmab and Michael Moran from AbbVie Discuss the Conditional EC Approval of TEPKINLY in a Stimulating Conversation with PharmaShots

Insights+: EMA Marketing Authorization of New Drugs in October 2023

Insights+: EMA Marketing Authorization of New Drugs in September 2023

New Drug Designations – August 2023

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