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Top Pharmaceutical Business Review News

Ferrer Receives FDA Fast Track Designation for FNP-223 in Progressive Supranuclear Palsy (PSP)
Business · Barcelona

Ferrer Receives FDA Fast Track Designation for FNP-223 in Progressive Supranuclear Palsy (PSP)

Coverage: 5 sources
BARCELONA, Spain--(BUSINESS WIRE)--Jun 17, 2025-See the Story
FDA Approves Plus Therapeutics’ Reyobiq for Paediatric Brain Cancer
Cancer · Madrid

FDA Approves Plus Therapeutics’ Reyobiq for Paediatric Brain Cancer

100% Left coverage: 1 sources
Paediatric HGG, including ependymoma, are not only rare but also very difficult to treat, with current standard care failing to prevent recurrence and with five-year survival rates. Reyobiq The post FDA approves Plus Therapeutics’ Reyobiq for paediatric brain cancer appeared first on Pharmaceutical Business review.See the Story
Simtra BioPharma Solutions Expands Facility in Germany
Germany · Germany

Simtra BioPharma Solutions Expands Facility in Germany

Simtra BioPharma Solutions has completed the construction of its new production manufacturing building at its campus in Halle, Germany.See the Story

Innovent Announces Mazdutide, First Dual GCG/GLP-1 Receptor Agonist, Received Approval From China's NMPA for Chronic Weight Management

SAN FRANCISCO and SUZHOU, China, June 27, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major…China · ChinaSee the Story

Mabwell signs Albipagrastim alfa deal with Qilu Pharmaceutical

This agreement grants Qilu exclusive rights to develop, manufacture, enhance, utilise and commercialise Albipagrastim alfa for Injection in Greater China including Chinese Mainland, Macau, Hong Kong and Taiwan. The post Mabwell signs Albipagrastim alfa deal with Qilu Pharmaceutical appeared first on Pharmaceutical Business review.Macau · MacauRead Article

EC grants orphan drug status to JR-446 for MPS IIIB

This follows a similar endorsement by the US Food and Drug Administration (FDA). Sanfilippo syndrome type B is an autosomal recessive disease marked by mutations in the N-acetyl-alpha-glucosaminidase The post EC grants orphan drug status to JR-446 for MPS IIIB appeared first on Pharmaceutical Business review.FDARead Article

Optime Care collaborates with Tilde Sciences for Vecamyl tablets

This collaboration appoints Optime Care as the exclusive specialty pharmacy provider for the newly FDA-approved tablets, ensuring the medication’s availability to patients.  Optime Care general manager Bill Bertetto The post Optime Care collaborates with Tilde Sciences for Vecamyl tablets appeared first on Pharmaceutical Business review.Read Article

Archeus Technologies Gets FDA Approval for ART-101 Application

This new small molecule is designed for prostate cancer imaging and treatment.   The FDA’s approval allows Archeus to begin a Phase I clinical study targeting metastatic castration-resistant prostate The post Archeus Technologies gets FDA approval for ART-101 application appeared first on Pharmaceutical Business review.United States · United StatesSee the Story

CHMP endorses ExCellThera's stem cell transplantation product

The therapy is intended to treat the adult population with haematological malignancies needing an allogeneic haematopoietic stem cell transplantation after a myeloablative conditioning for those individuals with no The post CHMP endorses ExCellThera’s stem cell transplantation product appeared first on Pharmaceutical Business review.Read Article

Johnson & Johnson submits sBLA to FDA to extend use of ustekinumab

The application is underpinned by the multi-centre, open-label Phase III UNITI-Jr clinical trial data, which assessed the therapy’s safety, pharmacokinetics, and efficacy in paediatric subjects. At present, Stelara The post Johnson & Johnson submits sBLA to FDA to extend use of ustekinumab appeared first on Pharmaceutical Business review.United States · United StatesRead Article

Solascure Receives FDA Fast Track Designation for Aurase Wound Gel to Treat Calciphylaxis Ulcers

100% Center coverage: 1 sources
SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound healing, today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational Aurase Wound Gel (AWG), in the treatment of patients with calciphylaxis ulcers.United States · United StatesSee the Story

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