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With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K inhibitor Piqray, which last year generated $505 million in revenue.

Glenmark Pharmaceuticals Inc. is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP 10 mEq K, to the consumer level.

Intelligent Bio Solutions Inc. today announced the successful completion of the in-clinic portion of its pharmacokinetic (PK) study, a core component of the Company’s clinical study plan for its 510(k) pathway for regulatory approval.

FSD Pharma Inc. (NASDAQ:HUGE)(CSE:HUGE)(FRA:0K9A) (“FSD Pharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions is pleased to provide the following corporate update.

Intelligent Bio Solutions Inc. today announced that it is entering the next phase of its planned 510(k) submission to the FDA.

Bridgewest Perth Pharma announced that Cyrus K. Mirsaidi is taking the worldwide helm as CEO, including its pharmaceutical supplier division, LumaCina, and its Contract Development and Manufacturing Organization division, NovaCina.

Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced that the Galien Foundation has awarded the 2024 Prix Galien U.K. Award for Best Pharmaceutical Product to Pombiliti® (cipaglucosidase alfa) + Opfolda® (miglustat).

FX received 510k clearance for its full-wedge augmented glenoid baseplates.

InnoVoyce today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the VYLO™ Laser System.