Sound's for hearing loss: Co's drug wins FDA breakthrough tag for Meniere’s disease

Here's a new ray of hope for new hope for patients suffering from Meniere’s disease (MD) and sensorineural hearing loss

FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA

Merck KGaA’s Cladribine capsules gain FDA fast track for rare neuromuscular disorder

Bayer’s experimental stroke drug could reshape secondary stroke prevention

Millions of stroke survivors across the world may soon have a new defense

Merck to acquire Cidara Therapeutics for $9.2 billion

Diversifying its portfolio to include late-phase antiviral agent

Teva reports 11th consecutive quarter of growth

Teva reported third quarter revenues of $4.5 billion, an increase of 3 per cent year-over-year.

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability

MIRA Pharmaceuticals advances oral Ketamir-2 into Phase 1 MAD study for chemotherapy-induced neuropathic pain

Advancing toward Phase 2a evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track designation

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company