On September 3, the FDA approved Zilganersen (ION373) (Ionis, IONS) in Alexander disease.
On September 4, the FDA approved Etcamah (camizestrant) (AZN).
September 11: the FDA is due to decide on TLX101-Px (Telix Pharmaceuticals Limited, TLX) in Recurrent or progressive glioma (brain cancer). That is the goal date; the agency can act earlier or extend it.
September 19: the FDA is due to decide on UX111 - (ABO-102) (Ultragenyx Pharmaceutical Inc., RARE) in Sanfilippo syndrome type A (MPS IIIA). That is the goal date; the agency can act earlier or extend it.
September 21: the FDA is due to decide on WINREVAIR (sotatercept-csrk) - (HYPERION) (Merck & Co., Inc., MRK) in Recently diagnosed pulmonary arterial hypertension (label update). That is the goal date; the agency can act earlier or extend it.
September 26: the FDA is due to decide on zilurgisertib (INCYTE CORP, INCY). That is the goal date; the agency can act earlier or extend it.
September 26: the FDA is due to decide on zilurgisertib (Mirum Pharmaceuticals, Inc., MIRM). That is the goal date; the agency can act earlier or extend it.
September 28: the FDA is due to decide on Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series (Biofrontera Inc., BFRI) in Basal cell carcinoma. That is the goal date; the agency can act earlier or extend it.
September 30: the FDA is due to decide on Mim8 (denecimig) (Novo Nordisk A/S, NVO) in Hemophilia A prophylaxis, with or without inhibitors. That is the goal date; the agency can act earlier or extend it.
October 9: the FDA is due to decide on Tecentriq (atezolizumab) adjuvant - (stage III colon) (Roche Holding AG, RHHBY) in Adjuvant stage III dMMR/MSI-H colon cancer. That is the goal date; the agency can act earlier or extend it.
October 10: the FDA is due to decide on Ifinatamab deruxtecan (I-DXd) (Merck, MRK) in Extensive-stage small cell lung cancer. That is the goal date; the agency can act earlier or extend it.
October 15: the FDA is due to decide on Enspryng (satralizumab) - (thyroid eye disease) (Roche Holding AG, RHHBY) in Thyroid eye disease (TED). That is the goal date; the agency can act earlier or extend it.
October 17: the FDA is due to decide on Phentolamine ophthalmic solution 0.75% (Opus Genetics, Inc., IRD) in Presbyopia (sNDA). That is the goal date; the agency can act earlier or extend it.
October 17: the FDA is due to decide on MR-141 (phentolamine ophthalmic solution 0.75%) (Viatris Inc, VTRS). That is the goal date; the agency can act earlier or extend it.
October 24: the FDA is due to decide on Leniolisib (Pharming Group N.V., PHAR) in APDS. That is the goal date; the agency can act earlier or extend it.
October 26: the FDA is due to decide on Bepirovirsen - (B-Well) (GSK plc, GSK) in Chronic hepatitis B. That is the goal date; the agency can act earlier or extend it.
October 30: the FDA is due to decide on INO-3107 DNA immunotherapy (Inovio Pharmaceuticals, INO) in Recurrent respiratory papillomatosis (RRP) BLA. That is the goal date; the agency can act earlier or extend it.
Dates and outcomes only, each linked to its record; see the full calendar and what a PDUFA date is. Not a prediction about any pending application, and not investment advice.