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Results For "United-States"

1202 News Found

Briefs: Biocon, Aarti Drugs and Glenmark Pharmaceuticals
Drug Approval | September 22, 2024

Briefs: Biocon, Aarti Drugs and Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations


Briefs: Dr. Reddy's Laboratories and Torrent Pharmaceuticals
Drug Approval | September 20, 2024

Briefs: Dr. Reddy's Laboratories and Torrent Pharmaceuticals

USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation


Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers
Clinical Trials | September 20, 2024

Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers

Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma


Lupin receives USFDA approval for Bumetanide Injection
Drug Approval | September 19, 2024

Lupin receives USFDA approval for Bumetanide Injection

Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.


Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis
Drug Approval | September 19, 2024

Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis

This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally


Briefs: Eugia Steriles and Shelter Pharma
Drug Approval | September 18, 2024

Briefs: Eugia Steriles and Shelter Pharma

Eugia Steriles receives EIR from USFDA for new injectable facility


10 year data for Merck’s Keytruda demonstrates sustained overall survival benefit versus Ipilimumab in advanced melanoma
Clinical Trials | September 16, 2024

10 year data for Merck’s Keytruda demonstrates sustained overall survival benefit versus Ipilimumab in advanced melanoma

At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated with ipilimumab


FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy
Drug Approval | September 16, 2024

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous


Strides receives USFDA approval for Fluoxetine Tabs 60 mg
Drug Approval | September 16, 2024

Strides receives USFDA approval for Fluoxetine Tabs 60 mg

Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules


Global Bio India unveils 30 breakthrough startups: Dr. Jitendra Singh
Policy | September 14, 2024

Global Bio India unveils 30 breakthrough startups: Dr. Jitendra Singh

India's bio economy has experienced remarkable growth, skyrocketing from US $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030