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US FDA UPDATE
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News
US FDA completes pre-license inspection at CPC Scientific’s Hangzhou cGMP manufacturing facility for Hepcludex API
,
August 07, 2026
Takeda’s oral orexin receptor 2 agonist, Orzeyful receives US FDA approval to treat the underlying cause of narcolepsy type 1
,
August 07, 2026
US FDA accepts Merck’s sBLA for Enflonsia to update its RSV LRTD indication to include children under two years at increased risk for severe RSV for their second season
,
August 07, 2026
Reckitt receives US FDA approval for Mucinex 12HR Cold & Fever Multi-Symptom
,
August 06, 2026
UK’s Innovative Licensing and Access Pathway grants Innovation Passports to investigational products for cancer and dementia
,
August 06, 2026
CervoMed’s neflamapimod awarded Innovation Passport Designation under the UK ILAP for treatment of dementia with Lewy bodies
,
August 05, 2026
Pathos AI inks collaboration and co-exclusive licensing agreement with AstraZeneca to advance novel ERa PROTAC for ER+ breast cancer into the clinic
,
August 05, 2026
Innogen Pharma’s Efsubaglutide alfa manufacturing facility in Suzhou receives Brazilian ANVISA PIC/S GMP certification
,
August 05, 2026
European Commission approves Sanofi’s MenQuadfi for use in infants from age six weeks against invasive meningococcal disease
,
August 05, 2026
US FDA grants fast track designation to Aravax’s PVX108, a next-generation immunotherapy to treat peanut allergy
,
August 04, 2026
Eli Lilly's olomorasib receives US FDA's Breakthrough Therapy designation to treat previously treated KRAS G12C-mutant advanced pancreatic cancer
,
August 04, 2026
GSI Group Holdings expands platform with acquisition of Aven Tools
,
August 04, 2026
Supernus Pharma & Indivior Pharma to merge to create a leading diversified CNS biopharma company with significant scale
,
August 04, 2026
US FDA clears Ractigen Therapeutics’ IND application for first-in-class saRNA candidate RAG-1C to treat Proliferative Vitreoretinopathy
,
August 03, 2026
US FDA & EMA accepts for review Polpharma Biologics’ BLA & MAA respectively, for PB016, a proposed vedolizumab biosimilar
,
August 03, 2026
Novartis’ Pluvicto receives US FDA approval for PSMA+ metastatic hormone-sensitive prostate cancer
,
August 03, 2026
Karyopharm to submit sNDA to US FDA in Aug 2026 seeking accelerated approval of selinexor in combo with ruxolitinib to treat myelofibrosis
,
August 01, 2026
Replimune announces favourable outcome from US FDA’s Advisory Committee meeting for RP1 in advanced melanoma
,
August 01, 2026
Meitheal Pharmaceuticals receives US FDA approval for Garzulys injection
,
August 01, 2026
US FDA grants priority review status to Johnson & Johnson’s sBLA for Rybrevant Faspro for adults with recurrent or metastatic HNSCC
,
August 01, 2026
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