📁 All Events (14251 stories)
Ascendis Pharma has ended the internal development of its IL-2 candidate. This decision signifies a pivot away from oncology expansion. The company had previously considered this asset for accelerated approval.
Ascendis Pharma has ended the internal development of its IL-2 candidate. This decision signifies a pivot away from oncology expansion. The company had previously considered this asset for accelerated approval.
fda_approval: selinexor — None
Ipsen has discontinued two liver disease drug candidates that were acquired from Albireo in 2023. One of these assets has been entirely set aside following the $952 million acquisition of Albireo.
Ipsen has discontinued two liver disease drug candidates that were acquired from Albireo in 2023. One of these assets has been entirely set aside following the $952 million acquisition of Albireo.
The FDA granted regular approval to rucaparib (Rubraca) on December 17, 2025. This approval is for adults with deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with an androgen receptor-directed therapy.
The FDA granted regular approval to rucaparib (Rubraca) on December 17, 2025. This approval is for adults with deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with an androgen receptor-directed therapy.
The FDA granted accelerated approval to rucaparib for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer.
The FDA granted accelerated approval to rucaparib for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer.
On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo) from Eli Lilly and Company. This approval is for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation.
On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo) from Eli Lilly and Company. This approval is for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation.
The FDA's May docket includes at least five PDUFA dates for regulatory decisions. These decisions pertain to one new product submitted via the 505(b)(2) pathway and four label expansions for existing products.
The FDA's May docket includes at least five PDUFA dates for regulatory decisions. These decisions pertain to one new product submitted via the 505(b)(2) pathway and four label expansions for existing products.
Gallant has advanced its IV-delivered stem cell therapy for canine osteoarthritis, receiving eligibility for expanded FDA-CVM conditional approval. The company is targeting conditional approval in 2028, supported by promising pilot data.
Gallant has advanced its IV-delivered stem cell therapy for canine osteoarthritis, receiving eligibility for expanded FDA-CVM conditional approval. The company is targeting conditional approval in 2028, supported by promising pilot data.
Pfizer has abandoned the remaining clinical-stage CD47 blocker and a T-cell engager, which were acquired through its $2.3 billion acquisition of Trillium Therapeutics. This decision signifies the failure of Pfizer's investment, as all candidates from the Trillium acquisition have now been scrapped.
Pfizer has abandoned the remaining clinical-stage CD47 blocker and a T-cell engager, which were acquired through its $2.3 billion acquisition of Trillium Therapeutics. This decision signifies the failure of Pfizer's investment, as all candidates from the Trillium acquisition have now been scrapped.
Viridian Therapeutics' anti-IGF-1R antibody met its primary endpoint in a second Phase 3 trial. This result clears the path for the company to file for FDA approval next year, aiming to challenge Amgen in the blockbuster market.
Viridian Therapeutics' anti-IGF-1R antibody met its primary endpoint in a second Phase 3 trial. This result clears the path for the company to file for FDA approval next year, aiming to challenge Amgen in the blockbuster market.
Disability improvement (offset effect)most prominent in pwRMSLong-term progression rateshighest in pwPPMSHazard ratio on EDSS-CDP endpointmostly influenced by the magnitude of the offset effect
Gossamer Bio, Inc. (GOSS) is facing a securities class action lawsuit following an 80% drop in its stock price due to the failure of its Phase 3 PROSERA trial. The lawsuit, filed by Hagens Berman, seeks to represent investors who acquired Gossamer securities between June 16, 2025, and February 20, 2026.
Gossamer Bio, Inc. (GOSS) is facing a securities class action lawsuit following an 80% drop in its stock price due to the failure of its Phase 3 PROSERA trial. The lawsuit, filed by Hagens Berman, seeks to represent investors who acquired Gossamer securities between June 16, 2025, and February 20, 2
Disability improvement (offset effect)most prominent in pwRMSLong-term progression rateshighest in pwPPMSHazard ratio on EDSS-CDP endpointmostly influenced by the magnitude of the offset effect
Lannett, its wholly owned subsidiary Lanexa Biologics, and Sunshine Lake Pharma have secured FDA approval for their drug Langlara.
Lannett, its wholly owned subsidiary Lanexa Biologics, and Sunshine Lake Pharma have secured FDA approval for their drug Langlara.
IDEAYA Biosciences announced that its Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint. The company plans to initiate the RTOR submission process with the first pre-submission in May, targeting completion of the NDA filing.
IDEAYA Biosciences announced that its Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint. The company plans to initiate the RTOR submission process with the first pre-submission in May, targeting completion of the NDA filing.
Disability improvement (offset effect)most prominent in pwRMSLong-term progression rateshighest in pwPPMSHazard ratio on EDSS-CDP endpointmostly influenced by the magnitude of the offset effect
Lupin Limited announced on May 5, 2026, that it has received approval from the United States Food and Drug Administration (FDA) for its Glycerol Phenylbutyrate Oral Liquid.
Lupin Limited announced on May 5, 2026, that it has received approval from the United States Food and Drug Administration (FDA) for its Glycerol Phenylbutyrate Oral Liquid.
EMA Approval: Palsonify (Crinetics Pharmaceuticals Europe GmbH)
Active substance: paltusotine hydrochloride | EC Decision: 23/04/2026 | Status: Authorised | Flags: Orphan | Area: Acromegaly | Papers: Paltusotine Hydrochloride. (American Journal of Health-System Pharmacy 2025); Acromegaly Disease Control Maintained After Switching From Injected Somatostatin (Jour
On September 10, 2025, the FDA approved selumetinib (KOSELUGO) from AstraZeneca Pharmaceuticals LP. This approval is for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
On September 10, 2025, the FDA approved selumetinib (KOSELUGO) from AstraZeneca Pharmaceuticals LP. This approval is for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
On March 19, 2025, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy. This approval is for locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1).
On March 19, 2025, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy. This approval is for locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma expr