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Results For "Medicines-and-Healthcare-products-Regulatory-Agency"

51 News Found

Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals
News | December 31, 2024

Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals

Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million


CuraTeQ Biologics receives approval for oncology biosimilar Bevqolva from UK's MHRA
News | December 22, 2024

CuraTeQ Biologics receives approval for oncology biosimilar Bevqolva from UK's MHRA

Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins


Dr. Reddy's launches Toripalimab in India
News | December 01, 2024

Dr. Reddy's launches Toripalimab in India

The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance


Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA
Drug Approval | April 22, 2024

Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA

NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A


Pfizer’s Velsipity UK approval will raise competition in ulcerative colitis market, says GlobalData
Drug Approval | April 06, 2024

Pfizer’s Velsipity UK approval will raise competition in ulcerative colitis market, says GlobalData

The approval marks a significant milestone for the American pharmaceutical company in the field of UC


Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data
Drug Approval | April 01, 2024

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024


Biocon's European partner Zentiva receives approval from UK MHRA for Liraglutide
Drug Approval | April 01, 2024

Biocon's European partner Zentiva receives approval from UK MHRA for Liraglutide

The company had earlier announced about the approval received from the MHRA for Liraglutide


Biocon to obtain approval for diabetes drug, Liraglutide in UK
Drug Approval | March 28, 2024

Biocon to obtain approval for diabetes drug, Liraglutide in UK

Liraglutide is a drug-device combination formulation used in the treatment of Type 2 Diabetes Mellitus