⚡ Top Events Today
Pfizer scraps remaining assets from $2.3B Trillium acquisition, marking a total failure.
Pfizer has abandoned all clinical-stage candidates acquired through its $2.3 billion acquisition of Trillium Therapeutics.
Viridian's Tepezza rival succeeds in second Phase 3 trial, clearing path for FDA filing.
The drug met its primary endpoint in a second Phase 3 trial, with the company planning an FDA submission next year.
Gossamer Bio faces class-action lawsuit after Phase 3 failure leads to 80% stock drop.
The company's stock dropped 80% following the failure of its Phase 3 PROSERA trial, triggering a securities class action lawsuit.
IDEAYA's darovasertib combo meets primary endpoint in registrational trial for uveal melanoma.
The Phase 2/3 OptimUM-02 trial met its primary endpoint, and the company plans to initiate the RTOR submission process with the FDA.
Crinetics Pharma secures EMA approval for Palsonify (paltusotine) for acromegaly.
The European Medicines Agency (EMA) has granted marketing authorisation for Palsonify, an oral, once-daily treatment for acromegaly.
📁 All Events (14176 stories)
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.
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
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.
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
Axsome Therapeutics' Auvelity has received FDA approval for the treatment of agitation associated with Alzheimer's disease. This marks the second FDA approval for Auvelity, following its initial nod four years ago for major depressive disorder.
Axsome Therapeutics' Auvelity has received FDA approval for the treatment of agitation associated with Alzheimer's disease. This marks the second FDA approval for Auvelity, following its initial nod four years ago for major depressive disorder.
The FDA granted early approval to Veppanu, developed by Pfizer and Arvinas, for a certain breast cancer subtype. Despite this early approval, Pfizer and Arvinas intend to leave the commercialization of Veppanu to a yet-to-be-identified partner.
The FDA granted early approval to Veppanu, developed by Pfizer and Arvinas, for a certain breast cancer subtype. Despite this early approval, Pfizer and Arvinas intend to leave the commercialization of Veppanu to a yet-to-be-identified partner.
A dual-vector gene therapy for hearing loss has secured its first FDA approval. This marks a significant regulatory milestone for the treatment of hearing loss.
A dual-vector gene therapy for hearing loss has secured its first FDA approval. This marks a significant regulatory milestone for the treatment of hearing loss.
The FDA has approved ROMVIMZA for patients with TGCT. This approval was based on safety and efficacy evidence from one clinical trial (NCT05059262) involving 123 patients.
The FDA has approved ROMVIMZA for patients with TGCT. This approval was based on safety and efficacy evidence from one clinical trial (NCT05059262) involving 123 patients.
This listing includes accelerated approvals for malignant hematology and oncology indications. These approvals have postmarketing requirements for ongoing clinical trials to verify clinical benefit.
This listing includes accelerated approvals for malignant hematology and oncology indications. These approvals have postmarketing requirements for ongoing clinical trials to verify clinical benefit.
The FDA has approved vepdegestrant for the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The FDA has approved vepdegestrant for the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The FDA approved Pfizer and Arvinas' drug vepdegestrant for patients with a certain form of breast cancer on Friday. This approval was granted despite the data being described as underwhelming, leading to uncertainty about its future adoption.
The FDA approved Pfizer and Arvinas' drug vepdegestrant for patients with a certain form of breast cancer on Friday. This approval was granted despite the data being described as underwhelming, leading to uncertainty about its future adoption.
The U.S. Food and Drug Administration (FDA) has approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets. This approval is for the treatment of agitation associated with dementia due to Alzheimer’s disease in adults. Auvelity is noted as the first non-antipsychotic drug to receive this approval.
The U.S. Food and Drug Administration (FDA) has approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets. This approval is for the treatment of agitation associated with dementia due to Alzheimer’s disease in adults. Auvelity is noted
Bristol Myers Squibb's cancer drug Krazati failed its confirmatory study in second-line colorectal cancer. This failure puts its accelerated approval, granted in 2024 for this setting, at risk.
Bristol Myers Squibb's cancer drug Krazati failed its confirmatory study in second-line colorectal cancer. This failure puts its accelerated approval, granted in 2024 for this setting, at risk.