monthly-news-roundup---august-2025

FDA Grants Accelerated Approval for First Treatment for Barth Syndrome, Forzinity

drugs.com - 25/Sep 17:09

THURSDAY, Sept. 25, 2025 -- The U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first...

FDA Grants Accelerated Approval for First Treatment for Barth Syndrome

drugs.com - 25/Sep 17:44

THURSDAY, Sept. 25, 2025 -- The U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first...

FDA Grants Accelerated Approval for First Treatment for Barth Syndrome

drugs.com - 25/Sep 17:44

THURSDAY, Sept. 25, 2025 -- The U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first...

Hims & Hers shares drop 6% after FDA warning on semaglutide marketing claims

wn.com - 16/Sep 20:15

Hims & Hers Health Inc. (NYSE: HIMS) saw its stock fall 6% on Tuesday following the release of a warning letter from the US Food and Drug...

US FDA grants breakthrough therapy designation to Daiichi Sankyo & Merck's raludotatug deruxtecan for patients with CDH6 expressing platinum─resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab

pharmabiz.com - 16/Sep 04:28

Raludotatug deruxtecan (R─DXd) has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the...

Apple Watch Gets FDA Clearance for Hypertension Monitoring

medindia.net - 18/Sep 06:35

Apple has received clearance from the US Food and Drug Administration (FDA) for a new Apple Watch feature that monitors medlinkhypertension...

FDA Approves Subcutaneous Tremfya Induction Treatment for Ulcerative Colitis

drugs.com - 24/Sep 21:09

WEDNESDAY, Sept. 24, 2025 -- The U.S. Food and Drug Administration has approved a subcutaneous (SC) induction regimen of Tremfya (guselkumab) for the...

FDA Approves Subcutaneous Tremfya Induction Treatment for Ulcerative Colitis

drugs.com - 24/Sep 21:09

WEDNESDAY, Sept. 24, 2025 -- The U.S. Food and Drug Administration has approved a subcutaneous (SC) induction regimen of Tremfya (guselkumab) for the...

FDA takes action to make a treatment available for Autism Symptoms

caribbeannewsglobal.com - 23/Sep 01:03

WASHINGTON, USA – The US Food and Drug Administration has initiated the approval of leucovorin calcium tablets for patients with cerebral folate...

Raludotatug Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Previously Treated with Bevacizumab

drugs.com - 15/Sep 01:09

BASKING RIDGE, N.J. AND RAHWAY, N.J., September 15, 2025 – Raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation...

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Monthly News Roundup - August 2025

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FDA Grants Accelerated Approval for First Treatment for Barth Syndrome, Forzinity

FDA Grants Accelerated Approval for First Treatment for Barth Syndrome

FDA Grants Accelerated Approval for First Treatment for Barth Syndrome

Hims & Hers shares drop 6% after FDA warning on semaglutide marketing claims

US FDA grants breakthrough therapy designation to Daiichi Sankyo & Merck's raludotatug deruxtecan for patients with CDH6 expressing platinum─resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab

Apple Watch Gets FDA Clearance for Hypertension Monitoring

FDA Approves Subcutaneous Tremfya Induction Treatment for Ulcerative Colitis

FDA Approves Subcutaneous Tremfya Induction Treatment for Ulcerative Colitis

FDA takes action to make a treatment available for Autism Symptoms

Raludotatug Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Previously Treated with Bevacizumab

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