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
Fresh Phase 1b/2a data highlight the strength of the iberdomide + daratumumab + dexamethasone combination in transplant-deferred or ineligible NDMM
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
LANXESS Biosecurity Solutions aims to deliver “advanced disinfection and hygiene solutions to support Indian farmers in maintaining healthier and safer farm environments
Phase one of the expansion will convert an existing hall into an ISO 7-certified cleanroom for GMP-compliant production
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