Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets

Bisoprolol Fumarate Tablets are used to treat high blood pressure.

Sun Pharma and Cosmo announce territory expansion of license and supply agreements for WINLEVI

Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia.

Merck updates on Phase 3 Keynote-412 trial in advanced head and neck squamous cell carcinoma

Zydus receives final approval from the USFDA for Efinaconazole Topical Solution

Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).

Sumitomo Pharma Oncology receives Orphan Drug Designation for DSP-0390 for the treatment of brain cancer

The FDA's Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people

Zydus gets USFDA’s approval for Empagliflozin, Metformin Hydrochloride tablets

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dr. Reddy's Laboratories updates on PAI of formulations facility

The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.

Lupin’s Somerset manufacturing plant Receives EIR from US FDA

The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated

Cipla updates on US FDA product-specific pre-approval inspection

The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.

Ardelyx gets into $20 million financing agreement with HealthCare Royalty Partners

HealthCare Royalty Partners funding supports the ongoing launch of IBSRELA in the United States