Kamal Choudhury

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Articles

EU regulator backs conditional authorisation for Madrigal's liver disease drug

1 week ago | today.westlaw.com | Shinjini Ganguli |Sriparna Roy |Kamal Choudhury

(Reuters) -The European Union's drug regulator on Friday recommended conditional authorisation of Madrigal Pharmaceuticals' Rezdiffra, paving the way for it to become the first available treatment in the region for patients with a form of fatty liver...
Medtronic to separate diabetes business following recent struggles

1 month ago | ca.marketscreener.com | Kamal Choudhury |Puyaan Singh

Published on 2025-05-21 at 05:19, updated on 2025-05-21 at 08:07 (Reuters) -Medical device maker Medtronic said on Wednesday it plans to separate its diabetes business, which houses its insulin pumps and other wearable devices, into a stand-alone company and forecast 2026 adjusted profit below estimates. The unit has been struggling over the last few years following regulatory concerns over quality management and cybersecurity issues related to its certain devices.
Medtronic to separate diabetes business following recent struggles

1 month ago | marketscreener.com | Kamal Choudhury |Puyaan Singh

Published on 05/21/2025 at 05:19, updated on 05/21/2025 at 12:39 (Reuters) -Medical device maker Medtronic said on Wednesday it plans to separate its diabetes business, which houses its insulin pumps and other wearable devices, into a stand-alone company and forecast 2026 adjusted profit below estimates. The unit has been struggling over the last few years following regulatory concerns over quality management and cybersecurity issues related to its certain devices.
Medtronic to separate diabetes business following recent struggles

1 month ago | today.westlaw.com | Puyaan Singh |Sriparna Roy |Nivedita Bhattacharjee |Kamal Choudhury

(Reuters) -Medical device maker Medtronic said on Wednesday it plans to separate its diabetes business, which houses its insulin pumps and other wearable devices, into a stand-alone company and forecast 2026 adjusted profit below estimates.
Zimmer Biomet lowers 2025 profit forecast amid tariff uncertainty, shares fall

1 month ago | today.westlaw.com | Kamal Choudhury |Shailesh Kuber

(Reuters) - Zimmer Biomet Holdings on Monday lowered its 2025 adjusted profit forecast, and said it expects the proposed trade tariffs to weigh on the company's earnings this year. The Warsaw, Indiana-based company's shares fell 10% to $92 in morning...
US FDA approves first cell-based gene therapy for rare genetic skin disorder

1 month ago | azdailysun.com | Sneha K |Kamal Choudhury

By Sneha S K and Kamal Choudhury(Reuters) -The U.S. Food and Drug Administration approved Abeona Therapeutics' gene therapy for a rare skin disorder on Tuesday.
US FDA approves first cell-based gene therapy for rare genetic skin disorder

2 months ago | kfgo.com | Sneha K |Kamal Choudhury

By Sneha S K and Kamal Choudhury(Reuters) -The U.S. Food and Drug Administration approved Abeona Therapeutics’ gene therapy for a rare skin disorder on Tuesday. Shares of the Cleveland-based drugmaker rose 13% in premarket trading. The gene therapy, called Zevaskyn, is approved to treat adult and pediatric patients with recessive dystrophic epidermolysis bullosa.
US FDA approves first cell-based gene therapy for rare genetic skin disorder

2 months ago | kelo.com | Sneha K |Kamal Choudhury

By Sneha S K and Kamal Choudhury(Reuters) -The U.S. Food and Drug Administration approved Abeona Therapeutics’ gene therapy for a rare skin disorder on Tuesday. Shares of the Cleveland-based drugmaker rose 13% in premarket trading. The gene therapy, called Zevaskyn, is approved to treat adult and pediatric patients with recessive dystrophic epidermolysis bullosa.
First Cell-Based Gene Therapy Approved

2 months ago | conexiant.com | Kamal Choudhury |Sneha K

The U.S. Food and Drug Administration approved Abeona Therapeutics' cell-based gene therapy, pz-cel (Zevaskyn), for recessive dystrophic epidermolysis bullosa (RDEB). Zevaskyn is approved for the treatment of adult and pediatric patients with RDEB. Patients with RDEB have markedly fragile skin, with recurrent blistering and chronic, nonhealing wounds.
US FDA limits industry employees from roles in its advisory committees

2 months ago | today.westlaw.com | Patrick Wingrove |Mohammed Shamsi |Savyata Mishra |Kamal Choudhury

(Reuters) -U.S. Food and Drug Administration Commissioner Martin Makary announced on Thursday a policy to limit employees of companies regulated by the agency, such as pharmaceutical firms, from serving as official members on FDA's advisory...