Registro de fonte primária
A FDA emitiu carta de advertência à Catalent Indiana (Novo Nordisk) após o Form 483 de julho de 2025; a inspeção da instalação foi classificada como official action indicated. A empresa realizou reunião Tipo A em 12 de novembro de 2025 e ainda orienta a ressubmissão da BLA e o lançamento do apitegromab na SMA durante 2026.
false 0001727196 0001727196 2025-12-02 2025-12-02 iso4217:USD xbrli:shares iso4217:USD xbrli:shares UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event Reported): December 2, 2025 Scholar Rock Holding Corporation (Exact Name of Registrant as Specified in Charter) Delaware 001-38501 82-3750435 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification Number) 301 Binney Street , 3rd Floor , Cambridge , MA 02142 (Address of Principal Executive Offices) (Zip Code) ( 857 ) 259-3860 (Registrant's telephone number, including area code) (Former name or former address, if changed
Scholar Rock: FDA Fast Track + Orphan Drug para apitegromab em FSHD