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1370 News Found

Lupin launches first generic version of Oracea in US
News | April 10, 2024

Lupin launches first generic version of Oracea in US

Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients


Bayer and Dr. Reddy's sign marketing and distribution agreement for second brand of Vericiguat in India
News | April 07, 2024

Bayer and Dr. Reddy's sign marketing and distribution agreement for second brand of Vericiguat in India

Vericiguat works on a pathway not currently targeted by existing heart failure treatments


USFDA approves Bristol Myers and 2seventy bio’s Abecma for triple-class exposed multiple myeloma
Drug Approval | April 06, 2024

USFDA approves Bristol Myers and 2seventy bio’s Abecma for triple-class exposed multiple myeloma

Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial


Enhertu approved in the US as first tumour-agnostic HER2-directed therapy
Drug Approval | April 06, 2024

Enhertu approved in the US as first tumour-agnostic HER2-directed therapy

Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers


EC expands Reblozyl’s approval for treatment of myelodysplastic syndromes
Drug Approval | April 03, 2024

EC expands Reblozyl’s approval for treatment of myelodysplastic syndromes

This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia


AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer
Drug Approval | April 02, 2024

AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer

Application based on results from the TROPION-Breast01 Phase III trial


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


Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer
Drug Approval | March 30, 2024

Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer

First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations


NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
Drug Approval | March 30, 2024

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy