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FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma
Drug Approval | May 30, 2024

FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma

Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients


Merck to acquire EyeBio for US$ 1.3 billion upfront payment
News | May 30, 2024

Merck to acquire EyeBio for US$ 1.3 billion upfront payment

Acquisition includes Restoret, a novel late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration


Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL
Drug Approval | May 29, 2024

Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL

Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation


Asahi Kasei to acquire Calliditas Therapeutics AB to accelerate growth
News | May 29, 2024

Asahi Kasei to acquire Calliditas Therapeutics AB to accelerate growth

Asahi Kasei will offer to acquire all of the ordinary shares of Calliditas


Alvotech and Dr. Reddy’s collaborate for commercialization of AVT03 (denosumab)
News | May 27, 2024

Alvotech and Dr. Reddy’s collaborate for commercialization of AVT03 (denosumab)

Dr. Reddy’s gets exclusive commercialization rights in the United States (U.S.) as well as semi-exclusive rights in Europe and United Kingdom (UK)


Zydus receives final approval from USFDA for Theophylline ER Tablets
Drug Approval | May 25, 2024

Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease


Cipla receives final approval for the generic version of Somatuline Depot Injection
Drug Approval | May 23, 2024

Cipla receives final approval for the generic version of Somatuline Depot Injection

Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (Lanreotide) Injection


Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili
Drug Approval | May 21, 2024

Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili

The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States


Glenmark receives ANDA approval for Brimonidine Tartrate and Timolol Maleate ophthalmic solution
Drug Approval | May 18, 2024

Glenmark receives ANDA approval for Brimonidine Tartrate and Timolol Maleate ophthalmic solution

According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market achieved annual sales of approximately $290.0 million


Zydus receives final approval from USFDA for Dexamethasone Tablets
Drug Approval | May 13, 2024

Zydus receives final approval from USFDA for Dexamethasone Tablets

Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)