EMA Marketing Authorization of New Drugs in November 2024

Shots: The EMA’s CHMP has granted positive opinions to 3 Biologics and 2 New Chemical Entities in November 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were AbbVie’s Elahere to treat Ovarian Cancer and Pfizer’s Hympavzi for Hemophilia A and B PharmaShots has compiled a list of…

ByDipanshu DixitDecember 19, 2024

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Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Shots: The EC has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs., at least 35kg) with hemophilia A & B, without FVIII & FIX inhibitors, respectively. It is valid across the EU plus Iceland, Liechtenstein & Norway Approval was based on pivotal P-III (BASIS) study of Hympavzi…

ByDipanshu DixitNovember 20, 2024

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The US FDA New Drug Approvals in October 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of October 2024 The US FDA has approved a total of 4 new drugs including 2 new molecular entities and 2 biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drugs were Pfizer’s Hympavzi for…

ByDipanshu DixitNovember 12, 2024

INSIGHTS+

EMA Marketing Authorization of New Drugs in September 2024

Shots: The EMA’s CHMP has granted positive opinion to 4 Biologics and 1 New Chemical Entity in September 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were AbbVie’s Elahere to treat Ovarian Cancer and Pfizer’s Hympavzi for Hemophilia A and B PharmaShots has compiled a list of 3 drugs that have been…

ByDipanshu DixitOctober 24, 2024

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Pfizer Reports the US FDA’s Approval of Hympavzi to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Shots: The US FDA has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively. It has also received the CHMP’s positive opinion for the same Results from pivotal P-III (BASIS) study, assessing Hympavzi in patients (12-75yrs.) with severe…

ByDipanshu DixitOctober 11, 2024

News

Pfizer Reports the CHMP’s Positive Opinion of Hympavzi (Marstacimab) to Treat Hemophilia A and B

Shots: The CHMP has recommended Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively The opinion was based on data of 116 subjects (12-75yrs.) from a pivotal P-III (BASIS) study treated with marstacimab (300mg loading dose followed by…

ByDipanshu DixitSeptember 20, 2024

EMA Marketing Authorization of New Drugs in November 2024

Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

The US FDA New Drug Approvals in October 2024

EMA Marketing Authorization of New Drugs in September 2024

Pfizer Reports the US FDA’s Approval of Hympavzi to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Pfizer Reports the CHMP’s Positive Opinion of Hympavzi (Marstacimab) to Treat Hemophilia A and B

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EMA Marketing Authorization of New Drugs in November 2024

Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

The US FDA New Drug Approvals in October 2024

EMA Marketing Authorization of New Drugs in September 2024

Pfizer Reports the US FDA’s Approval of Hympavzi to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Pfizer Reports the CHMP’s Positive Opinion of Hympavzi (Marstacimab) to Treat Hemophilia A and B

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