Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

Shots: Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…

ByPrince GiriDecember 8, 2025

NEWS

The US FDA Approves Lupin’s Armlupeg (Biosimilar, Neulasta)

Shots: The US FDA has approved Armlupeg (pegfilgrastim-unne) as a biosimilar version of Neulasta (pegfilgrastim) Armlupeg (6 mg/0.6 mL) is administered as a single-dose SC injection. It is indicated to reduce the incidence of febrile neutropenia in pts with non-myeloid cancers undergoing myelosuppressive CT and to improve survival following acute myelosuppressive radiation exposure Armlupeg will be produced at Lupin’s Biotech facility…

ByDipanshu DixitDecember 1, 2025

NEWS

RION Launches RION Vet to Advance Platelet-Derived Biologics in Animal Health

Shots: RION has launched RION Vet, a veterinary biotechnology subsidiary, with exclusive global rights to RION’s exosome-based therapeutic platform for animal health RION Vet is developing ePEP-01, a cell-free, shelf-stable platelet-derived biologic, for equine musculoskeletal disorders, which was evaluated in over 50 horses for >4yrs., showing improvement in lameness, with favorable safety RION Vet leverages…

ByRidhi RastogiNovember 12, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in September 2025

Shots: The EMA’s CHMP has granted approvals to 5 Biologics and 5 new chemical entities in September 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug, Merck’s Enflonsia, has Adopted Positive Opinion for RSV Prevention in Infants PharmaShots has compiled a list of 9 drugs that have been…

ByDipanshu DixitOctober 21, 2025

NEWS

Halozyme Therapeutics to Acquire Elektrofi for ~$900M, Expanding its Drug Delivery Offerings

Shots: Halozyme Therapeutics has entered into a definitive agreement to acquire Elektrofi, incl. its Hypercon technology, which enables biologic formulations at concentrations of 400-500mg/ml As per the deal, Elektrofi will receive $750M upfront, with up to three $50M milestone payments contingent on regulatory approvals of three separate Hypercon products; closing expected in Q4’25 As a result…

ByRidhi RastogiOctober 3, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in August 2025

Shots: The EMA’s CHMP has granted approvals to 1 Biologic and 3 new chemical entities in August 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Gilead’s Yeytuo has Secured the EC’s Approval for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV PharmaShots has compiled a list of 4…

ByDipanshu DixitSeptember 16, 2025

INSIGHTS+

New Drug Designations: July 2025

Shots:    PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA. The July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…

ByRidhi RastogiAugust 26, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in July 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 3 Biologics and 10 new chemical entities in July 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Roche’s Itovebi Secures the EC’s Approval for PIK3CA-mutated Breast Cancer PharmaShots has compiled a list of 13 drugs…

ByDipanshu DixitAugust 19, 2025

INSIGHTS+

The US FDA New Drug Approvals in July 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2025 The US FDA has approved a total of 6 new drugs, including 5 new molecular entities and 1 biologic, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Regeneron’s Lynozyfic, securing…

ByDipanshu DixitAugust 12, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in June 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 2 Biologics and 6 new chemical entities in June 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was SpringWorks Therapeutics’ Ogsiveo to Treat Desmoid Tumours PharmaShots has compiled a list of 8 drugs that have been…

ByDipanshu DixitJuly 22, 2025

Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

The US FDA Approves Lupin’s Armlupeg (Biosimilar, Neulasta)

RION Launches RION Vet to Advance Platelet-Derived Biologics in Animal Health

EMA Marketing Authorization of New Drugs in September 2025

Halozyme Therapeutics to Acquire Elektrofi for ~$900M, Expanding its Drug Delivery Offerings

EMA Marketing Authorization of New Drugs in August 2025

New Drug Designations: July 2025

EMA Marketing Authorization of New Drugs in July 2025

The US FDA New Drug Approvals in July 2025

EMA Marketing Authorization of New Drugs in June 2025

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