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
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
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
Under the proposed terms, Vaximm would secure a $20 million upfront payment, up to $815 million tied to clinical, regulatory, and commercial milestones
Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs
Selected proposals in the innovation challenge will receive funding to develop transformative ideas, tools, and approaches to strengthen early diagnosis and improve patient outcomes
The oral, film-coated tablet is licensed for patients whose cancer has returned during or shortly after hormone therapy
The audit was completed with zero critical and zero major observations
Nitrosamines have prompted evolving global guidelines that demand rigorous industry oversight
The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway
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