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FDA issues an early alert after becoming aware that Abiomed had issued a letter to affected customers recommending certain Automat...[ Price : $8.95]
FDA issues Biogen a complete response letter on a supplemental NDA for a high-dose regimen of Spinraza (nusinersen) for treating s...[ Price : $8.95]
FDA posts a final guidance outlining how the agency will decide when to temporarily allow use of unapproved diagnostic tests durin...[ Price : $8.95]
FDA grants accelerated approval to a Stealth Biotherapeutics NDA for Forzinity (elamipretide) injection for treating Barth syndrom...[ Price : $8.95]
FDA rejects Otsuka Pharmaceutical and H. Lundbecks sNDA to expand the use of Rexulti (brexpiprazole) for treating post-traumatic s...[ Price : $8.95]
FDA takes two actions against autism by ordering a label change against acetaminophen (Tylenol) use in pregnancy approving leucovo...[ Price : $8.95]
FDA extends by three months its review of Sanofis multiple sclerosis drug tolebrutinib to evaluate additional analyses submitted r...[ Price : $8.95]
Roche reports positive Phase 3 data with its investigational breast cancer drug giredestrant.