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
Patients can now get the starting 2.5 mg dose for $299 per month
At the heart of the showdown is a deep split among federal circuit courts over whether federal law overrides state failure-to-warn claims in Roundup personal-injury suits
Ilumya is the first IL-23 inhibitor to complete five years of study based on a pooled analysis of two Phase 3 efficacy and safety extension trials
Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs
Roche says the move marks a step forward in its digital transformation strategy
Under the proposed terms, Vaximm would secure a $20 million upfront payment, up to $815 million tied to clinical, regulatory, and commercial milestones
Phase one of the expansion will convert an existing hall into an ISO 7-certified cleanroom for GMP-compliant production
The MUSE system offers a minimally invasive solution for treating gastroesophageal reflux disease
The study, titled “A Large-Scale Efficacy Trial of a Resilience Training Program for First Responders,” will enroll 800 first responders in New York and Texas
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